Mohammad Arif has over 15 years of experience in clinical research and healthcare. He has extensive experience managing clinical trials from protocol development through study reporting. He has worked at The Medicines Company and Lenox Hill Hospital managing numerous cardiovascular clinical trials and studies. He has strong skills in project management, protocol development, site management, data management, and regulatory submissions.
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
Feasibility Solutions to Clinical Trial Nightmaresjbarag
Slow patient recruitment and poor retention cause recurrent nightmares and perpetual problems often resulting in missing recruitment milestones. The cost of these delays represents hundreds of thousands of dollars for drug and device developers. By recognizing this issue, early detailed feasibility can provide planning and contingency solutions that are focused on reducing the impact of delayed recruitment. Furthermore understanding what motivates investigators and patients to actively participate in clinical studies and how patient recruitment strategies and materials can support all stakeholders to complete studies on time are critical aspects of clinical study delivery planning.
During this presentation, an experienced Premier Research feasibility and patient recruitment specialist, reviewed feasibility approaches to address protocol evaluation as well as addressed influences on country selection, site distribution and patient recruitment strategies to provide for more effective clinical trial planning and conduct.
For more information, go to http://www.premier-research.com.
Role responsibilities of_a_clinical_research_coordsushant deshmukh
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Every clinical research project may have one or more study coordinators depending on the workload at the trial site. Clinical trials at site level can be roughly divided into 3 stages. The three stages and the role of the coordinators at these stages are:
1) Before starting the clinical trial
2) During the conduct of the clinical trial
3) After finishing the clinical trial
1) Before starting the clinical trial:
The final protocol (v5.3). Notable changes include:
1) Confirmation of audit standard (Page 6).
2) Refinement of inclusion and exclusion criteria (Page 7)
3) Confirmation of audit status (Appendix C)
4) Refinement of required data fields (Page 19) including definitions (Pages 20-25)
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Health research, clinical registries, electronic health records – how do they...Koray Atalag
This is a talk I gave at my own organisation - National Institute for Health Innovation (NIHI) of the University of Auckland on 6 Aug 2014. Abstract as follows:
In this talk I’ll first cover the topic of clinical registry – an invaluable tool for supporting clinical practice but also gaining momentum in research and quality improvement. NIHI has been very active in this space: we have delivered the prestigious and highly successful National Cardiac Registry (ANZACS-QI) together with VIEW research team and also very recently launched the Gestational Diabetes Registry with Counties Manukau DHB & Diabetes Projects Trust. A few others are in likely to come down the line. This is a huge opportunity for health data driven research and NIHI to position itself as ‘the health data steward’ in the country given our independent status and existing IT infrastructure and “good culture” of working with health data . NIHI’s ‘health informatics’ twist in delivering these projects is how we go about defining ‘information’ – using a scientifically credible and robust methodology: openEHR. This is an international (and now national too) standard to non-ambiguously define health information so that they are easy to understand and also are computable. We build software (even automatically in some cases!) using models created by this formalism. I’ll give basics of openEHR approach and then walk you through how to make sense out of all these. Hopefully you may have an idea about its ‘value proposition’ (as business people call) or Science merit as I like to call it ;)
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Health research, clinical registries, electronic health records – how do they...Koray Atalag
This is a talk I gave at my own organisation - National Institute for Health Innovation (NIHI) of the University of Auckland on 6 Aug 2014. Abstract as follows:
In this talk I’ll first cover the topic of clinical registry – an invaluable tool for supporting clinical practice but also gaining momentum in research and quality improvement. NIHI has been very active in this space: we have delivered the prestigious and highly successful National Cardiac Registry (ANZACS-QI) together with VIEW research team and also very recently launched the Gestational Diabetes Registry with Counties Manukau DHB & Diabetes Projects Trust. A few others are in likely to come down the line. This is a huge opportunity for health data driven research and NIHI to position itself as ‘the health data steward’ in the country given our independent status and existing IT infrastructure and “good culture” of working with health data . NIHI’s ‘health informatics’ twist in delivering these projects is how we go about defining ‘information’ – using a scientifically credible and robust methodology: openEHR. This is an international (and now national too) standard to non-ambiguously define health information so that they are easy to understand and also are computable. We build software (even automatically in some cases!) using models created by this formalism. I’ll give basics of openEHR approach and then walk you through how to make sense out of all these. Hopefully you may have an idea about its ‘value proposition’ (as business people call) or Science merit as I like to call it ;)
El Proyecto de la Empresa Mediana Española se consolida como plataforma de conocimiento y análisis de la realidad empresarial gracias al desarrollo de una serie de líneas de trabajo. Entre ellas destacamos los análisis monográficos, los debates y foros con expertos, el Informe Anual de la Empresa Mediana Española y el Top 50 de la Empresa Mediana Española.
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"Nevin Francis
Creating a comprehensive 3000-word essay on Good Clinical Practice (GCP) would be quite extensive and may not fit within the scope of our conversation here. However, I can provide you with a detailed outline and key points that you could expand upon to reach the desired word count.
**Introduction to Good Clinical Practice (GCP)**
- Definition and importance of GCP in clinical research.
- Historical development and international harmonization efforts.
**Ethical Considerations in GCP**
- The role of ethics in clinical trials.
- Informed consent process and protection of participants' rights.
**Designing Clinical Trials under GCP Guidelines**
- Key elements in the design of a clinical trial.
- Considerations for protocol development.
**Conducting Clinical Trials According to GCP**
- Responsibilities of sponsors and investigators.
- Patient recruitment and data management strategies.
**Safety Monitoring and Adverse Event Reporting**
- Monitoring patient safety and reporting adverse events.
- The role of Data Safety Monitoring Boards (DSMBs).
**Quality Assurance in Clinical Trials**
- Audits, inspections, and ensuring compliance with GCP.
- The significance of documentation and record-keeping.
**Statistical Considerations in Clinical Trials**
- Importance of statistical methods in trial design and analysis.
- Interpreting results and determining clinical significance.
**The Future of GCP and Clinical Research**
- Innovations in clinical trial methodology.
- The impact of technology on GCP and patient engagement.
**Conclusion**
- The ongoing importance of GCP for the integrity of clinical research.
- The global impact of GCP on healthcare and medicine.
Each of these sections can be elaborated to create a full essay that discusses the principles and practices of GCP in depth. For the most current and detailed information, you can refer to the ICH E6 (R2) Good Clinical Practice guidelines¹, which are recognized internationally and provide a comprehensive framework for conducting clinical trials that involve human subjects. Additionally, the draft version of the ICH E6 (R3) principles provides updated guidance on ethical trial conduct, participant safety, and reliable results².
Remember, while expanding on these points, it's essential to cite relevant guidelines, regulations, and literature to support your discussion and provide a well-rounded view of GCP.
Source: Conversation with Bing, 19/02/2024
(1) ICH E6 (R2) Good clinical practice - Scientific guideline. https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline.
(2) ICH-E6 Good Clinical Practice (GCP). https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf.
(3) ICH Guidance Documents | FDA. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents.
(4) Good Clinical Practice Guidelines (India) - Rajiv Gandhi Centre for .... https://www.rgcb.res.in/documents/Good-Clinical-Practice-Gu
Experienced Clinical Research Associate with over 5 years of experience in the clinical research in Excellent reputation for resolving problems, improving customer satisfaction, and driving overall operational improvements. Experience working on phases I, II and III clinical trials.
Investigator's Brochure - The Road Map for InvestigatorsClinosolIndia
The Investigator's Brochure (IB) is a crucial document in the realm of clinical research and drug development. It serves as a comprehensive reference guide for investigators, typically medical professionals conducting clinical trials, and provides essential information about the investigational product (drug or device) being studied. The IB is a road map that helps investigators understand the scientific, medical, and safety aspects of the product, ensuring that they can conduct the trial safely and effectively.
Current Trends in Clinical Trial Design and Execution ClinosolIndia
Adaptive Trial Designs: Adaptive trials allow for modifications to key aspects of a trial while it is ongoing, such as sample size, treatment arms, or endpoints. This flexibility can help optimize resources, reduce costs, and improve the efficiency of clinical trials.
Real-world Evidence (RWE): There is an increasing interest in incorporating real-world data and evidence into clinical trial design. RWE involves the use of data collected outside of traditional clinical trials, such as electronic health records, patient registries, and claims databases, to generate insights on treatment effectiveness, safety, and patient outcomes.
Patient-Centric Trials: There is a growing emphasis on patient-centricity in clinical trial design. This includes involving patients in trial planning, considering patient preferences, and incorporating patient-reported outcomes as endpoints. Patient-centric trials aim to improve patient recruitment, retention, and overall trial experience.
Virtual and Decentralized Trials: The COVID-19 pandemic has accelerated the adoption of virtual and decentralized trial approaches. These trials leverage digital technologies, remote monitoring, telemedicine, and home-based visits to reduce the need for frequent site visits and increase patient accessibility, particularly for those who may face geographical or mobility barriers.
Precision Medicine and Biomarker-Based Trials: Advances in genomics and molecular biology have led to an increased focus on precision medicine and biomarker-based trials. These trials aim to identify patient subgroups that are more likely to respond to specific treatments based on their genetic or biomarker profiles, allowing for more targeted and personalized approaches to therapy.
Data Analytics and Artificial Intelligence (AI): The use of data analytics and AI in clinical trial design and execution is gaining momentum. These technologies can help identify patterns, predict outcomes, optimize trial protocols, and streamline data collection and analysis processes, leading to more efficient and informed decision-making.
Collaborative and Platform Trials: Collaborative and platform trials involve partnerships between multiple stakeholders, including academia, industry, patient advocacy groups, and regulatory agencies. These trials aim to streamline trial operations, facilitate data sharing, and enable a more efficient evaluation of multiple interventions or treatment combinations simultaneously.
Risk-Based Monitoring: Traditional on-site monitoring of all trial sites can be resource-intensive. Risk-based monitoring focuses resources on higher-risk areas and uses a combination of centralized monitoring, statistical algorithms, and targeted on-site visits to ensure data quality and patient safety while optimizing resource utilization.
Regulatory Innovations: Regulatory agencies are increasingly exploring innovative approaches to support more efficient and accelerated clinical trials.
Regulatory requirements for drug approval unit3Aman chourasia
New Drug Application (NDA) is an application submitted to the individual regulatory authority for authorization to market a new drug i.e. innovative product. To gain this permission a sponsor submits preclinical and clinical test data for analyzing the drug information, description of manufacturing trials.
The Research Design & Conduct Service recently gave a presentation to staff at the Cardiff School of Medicine to let people know about their services, advice and support, which they offer to health professionals who are in the process of developing research projects. The RDCS was funded in 2010 by the National Institute for Social Care and Health Research (NISCHR), part of the Welsh Assembly Government. Their partner organisations are Cardiff and Vale University HB, Cwm Taf HB, Aneurin Bevan HB and Powys Teaching HB.
Learn more about the RDCS by viewing the presentation below and by visiting their website: http://medicine.cf.ac.uk/rdcs/
1. MOHAMMAD ARIF
627 Richmond Road • East Meadow, New York 11554 • (848) 391-7719
arifmohammad2227@gmail.com • www.linkedin.com/pub/mohammad-arif
Clinical Research Scientist
Extensive scientific, research, management, and training experience. Comprehensive knowledge in the
therapeutic areas of Cardiovascular, Endovascular, infectious diseases with added expertise in prevention and
treatment of Thrombo-Embolic events. Both hospital and industry based healthcare experience with a track
record of achieving successful trials within strict deadlines. Directly involved in team matrix interaction in the
execution of the study in a record short period of time such as project planning, protocol development, trial
design, ICF, CRF’s development, site management, data management, study drug pharmacology and safety.
Serving as a liaison, developed strong and credible relationships between sponsor and investigators, KOL’s,
and key stakeholders. Evaluates AE/SAE/SUSARS and supports interpretation, preparation and submission of
study reports to the authorities.
• Clinical Trials Project Management
• Clinical Data Management
• Protocol and Protocol Amendment Development
• Research Investigator and Staff Education
• Medical Monitor and Medical Info Support
• Training and Development
• Effective and Credible Communication
• Budget/Contract negotiation
Ta
EXPERIENCE
The Medicines Company Parsippany, NJ 11/2004-5/2015
Senior Clinical Operation Leads, Medical Monitor & Project Lead
End to end management of a clinical trial process from protocol development through study reporting.
• Supported internal and external customers in drafting study documents, protocols and ICF, CRF’s.
• Leveraged knowledge of handling clinical project budgets to ensure completion through final reporting
for both submission studies and exploratory work.
• Participated with all aspects of matrix structure, driving delivery of clinical studies within project teams.
• Coordinated internal/external resources for clinical trial planning, implementation and follow-ups.
• Mentored, recruited, trained, and supervised contract CRA’s and new sites for research projects and
patient enrollment.
• Supported sites for IRB submission of protocol, ICFs, contract and budget negotiation. Performed site
qualification and initiation visit to train physicians and research staff on the protocol and study logistics.
• Educated and trained the research team, pharmacists, and nursing staff of ED, ICU, and cath Lab.
• Provided specific education to SC with ref. to screening/consenting process, randomization process,
and study drugs, procedure coverage, CRF’s, source docs for SAE’s and PD.
• Managed site re-in-services and performed interim monitoring to follow-up study progress and to
address any specific issues
• Reviewed monitoring reports, followed-up on action plans, created new ideas and tools to help Internal
Regulatory team for QC process and helped sites to run studies according to rules and regulations.
• Coordinated CRO, SC, and sponsors in day-to-day operations of study enrollments.
• Provided global support to the Medical Affair team by answering protocol and clinical related questions
and resolving issues from the sites, PI, SC, and CRO’s.
• Coordinated, communicated and negotiated with vendors for study supplies, sample collection and
created a database for the final analysis
• Prepared internal compliance team and the sites for internal and FDA audits; provided support to
address the issues identified in these audits.
2. • Represented and supported internal team at national and international conferences; planned breakfast,
lunch and dinner meeting with KOL’s and investigators and supported research efforts at the exhibition
booths.
Lenox Hill Hospital, New York, NY 01/1999-11/2004
Interventional Cardiology, Clinical Research – Cardiovascular
• Provided support to physicians in coordinating Phase II, III and IV clinical trials.
• Recruited, screened and managed patients participating in clinical trials of different therapeutic areas.
• Supervised drug dispensing, inventory and accountability; collected and analyzed data; performed an
interoffice monitoring of case report forms and interacted with study monitors.
• Prepared necessary documentation for IRB/ FDA submission, budgets for upcoming studies, and
assisted in protocol preparation.
• Successfully prepared and conducted several FDA audits.
• Assisted in accumulating data for writing abstracts and reports for a variety of research projects.
• Participated in clinical investigator meetings, poster presentations, and live cases presentations.
• Created study related status reports and source documents.
• Produced and established Standard Operating Procedures for new research coordinators.
• Trained research staff with regards to GCP’s, ICH, and Federal regulations and day-to-day laboratory
operations.
• Provided troubleshooting services for various clinical studies and protocols interpretation.
Lenox Hill Hospital, New York, NY 02/1993-10/1999
Microbiology Technologist
Analyzed and processed a variety of Microbiology specimens in the laboratory.
• Performed pre-surgical procedure testing, including phlebotomy for blood culture, EKG, glucose
tolerance tests & HIV tests.
Medical Resident Experience, Karachi, Pakistan 04/1984-02/1989
• Medical Resident at Jinnah Post Graduate Medical Center
• Medical Resident at Dow Medical College
• Orthopedic Resident at Dow Medical College
• Cardiology Resident at Dow Medical College
• Surgical Resident at Dow Medical College
.
EDUCATION/PROFESSIONAL DEVELOPMENT
M.S. Health and Hospital Services Administration (MSHS)
IONA COLLEGE Westchester NY
M.B.B.S. (Medical Doctor – MD)
DOW MEDICAL COLLEGE Karachi Pakistan
Professional Awards:
Certificate in Long Term Care and Post-Acute Care Administration
Clinical Laboratory Technologist License NYC Dept. of Health
Clinical Laboratory Technologist
.
SKILLS
• GCP, ICH, IRB and Federal Regulations
• EKG/ Cardiac Work-up
• Laboratory Technology
• Immunohistochemistry
• Microsoft Word, Excel, PowerPoint
3. Mohammad Arif • 848.391.7719 • arifmohammad2227@gmail.com • Page 3
Mohammad Arif
Resume Addendum
Pharmacology Research:
• Randomized, multicenter, double-blind study to evaluate the efficacy of Tirofiban and Abciximab in
patients undergoing PTCI – Lenox Hill Hospital (April 2000 )
• Pharmacodynamic Assessment of two Tirofiban doses versus standard dose Abciximab during PTCI –
Lenox Hill Hospital (Dec. 1999).
• Association of platelet Glycoprotien IIIa polymorphism with platelet Aggregation and Myonecrosis in
coronary intervention. ( July 2000 )
• A phase II studies evaluating Intraluminal delivery of AVI-4126 in patients with focal De Novo stenosis or
in-stent restenosis, ( Nov. 2000 )
• A phase IIIb, multicenter, randomized, double blind, placebo-controlled study to determine the safety,
efficacy and tolerability of Fenoldopam Mesylate in subjects undergoing Intervention (.Nov. 2000 )
• Ionic versus Non-Ionic Contrast to obviate worsening Nephropathy after angioplasty in chronic renal
failure patients. (Dec. 2001)
• Prevention of restenosis with Tranilast and its outcome, placebo controlled trail. (Dec. 99 - Dec. 2000.)
• Treat angina with Aggrastat and determine the cost of therapy with invasive or conservative strategy
TIMI 18. (Feb. 99 – Dec. 99.)
• Randomized study to compare the effectiveness of Levinox with Un fractionated heparin in the
prevention of post proc. complication ( Aug.01- Feb. 02)
• Oral Rapamycin Trial in prevention of Restenosis in the patients with denovo lesions. (Nov. 01- Oct. 02).
• To find out the effects of Anti-Oxidant in the prevention of atherosclerosis in patients with CHD by
decreasing the demand of oxygen. (Feb. 02 )
• To find out the effects of AVANDIA in diabetic patient with CHD in the prevention of atherosclerosis.
(Feb. 02 )
• Randomized comparison of Angiomax VS Lovenox in pt. with Acute Coronary Syndrome without ST-
segment elevation.( Mar. 03 )
• Clinical Evaluation of the Concomitant Use of Angiomax and a Drug-Eluting Stent. (Jun. 03 )
• Clinical Evaluation of a study drug CSC-505 in preventing the progression of Atherosclerotic process in
the Coronary Artery System. (March 2002)
• Phase I & II Trial of Saphenous vein graft Angioplasty free of emboli – Randomized and Registry using
PercuSerge Guardwire plus Occlusion balloon.( Aug. 99 – Jun. 2001.)
Biomedical Device Research:
• Phase I & II Trial– CardioShield filter application to protects during Transluminal intervention of vein
grafts by reducing emboli. (Oct. 2000 )
• Phase I & II Trial – Filter wire system during transluminal intervention of saphenous vein grafts –
Feasibility/ Randomized, and in High Risk patients, multicenter trial. (Mar.2001 )
• Saphenous vein grafts intervention using BX Velocity stent with AngioGuard for reduction of distal
embolization. (Apr. 2000 – June 01.)
• Saphenous vein grafts intervention using balloon protected flush extraction system. Randomized,
multicenter trial-(Dec.2001-Nov.02.)
4. • X-sizer for the treatment of thrombus and arteriosclerosis in the saphenous vein graft intervention.
Randomized and AMI study. (Mar. 2000 - Oct. o2.)
• Sephanous vein graft intervention using Jo-med stent to prevent distal embolism and restenosis.( Aug,
2000-Sep. 02.)
• Evaluation of short-term use of AB-180 percutaneous Trans-septal Ventricular Assist system in patients
with cardiogenic shock. (May 00-Jul.-01).
• Three different stent registry trails from BiodivYsio, Biocompatible for the treatment of single De Novo
lesions. (July 2000 )
• Multicenter, Randomized, and Double blind study with Sirolimus- coated BX-Velocity stent in the
patients with De-Novo lesions. (Feb. 2001 )
• Evaluation of Orbus R-stent delivery system in patients with De-Novo lesion. (Sept.2000 )
• Randomized comparison of Multi-Link stent with or without Adjunctive Directional Coronary Atherectomy
(DCA) in the treatment of De-Novo and Restenosis Native lesions. (Jan.2000).
• Comparison of new stents with approved stents for the Equivalency of reduction in vascular events.
(July 2000 _
• A multicenter, feasibility in patients with Heparin-coated stent and anti-thrombotic regimen of Asprin
alone. (Dec 2000 – Jan. 2001.)
• Evaluation of the effects of Sonotherapy in post PTCA patients to prevent Neointimal Hyperplasia. (Jan.
2000 – July 2000).
• Two different studies for the evaluation of the effects of Safe-steer Guide wire system in the treatment of
chronic coronary artery total occlusion, using Radio-frequency Ocillograph Monitor. (Jan 2000).
• A pilot-dose Gamma Radiation therapy in the prevention of in-stent restenosis. As well as affects in
different lesion lengths as well as high-risk patients. (Gamma IV, V, and High Risk) ( Sept. 2000 )
• To evaluate the safety and effectiveness of Strontium Radiation therapy in patients with instent
restenosis, using Beta-Cath System. (Oct.2000 – 2001.)
• Phase 1, Open Label, pilot study, to evaluate the safety and feasibility of Transendocardial Delivery of
Autologous Bone marrow in patients with chronic Refractory Myocardial Ischemia. Mar. 2001 – present.
• A multicenter, feasibility stent trial in patients with DeNovo lesion/ AC/TAC condition.( Mar. 01-Nov. 02).
• A multicenter, feasibility trial to work as a future drug eluting stent in patients with DeNovo lesion. (Jun.
02- Nov. 02).
• A multicenter trial in patients with Bifurcating lesions with the help an extra side hole stent. (Feb. 02-
Dec. 02).
• A multicenter drug eluting stent registry trial in patients with Denovo lesion. (Mar.02- May. 02).
• A multicenter drug eluting stent registry trial in patients with Denovo lesion. (Mar. 02- May. 02)
• Phase I & II Trial – A multicenter feasibility trial in patients with Denovo and Restenotic lesions. (Jan, 01)
• A multicenter drug eluting stent with paclitaxel randomized trial in patients with Denovo lesion.( March
2002 )
• A multicenter randomized study comparing brachytherapy v/s rapamycin drug eluting stent in patiet with
instent restenosis.( March 2000 ).
• Preparation of Coronary Lesions using FX minirail balloon prior to Drug Eluting Stent Implantation.
( Mar. 03 )
• Proximal Protection during Saphenous Vein Grafts Intervention using the Proxis Embolic Protection
System.( Mar. 03 )
• Clinical Investigation of Spinal Cord Stimulation for the treatment of Refractory Angina.( Feb. 03 ).
Evaluation of the effects of FOXHOLLOW Coronary Debulking Catheter in the treatment of Bifurcation
Lesions in coronary arteries. ( Feb. 03 )
• Randomized trial evaluating the Slow-Release Formulation TAXUS Paclitaxel-Eluting Stent in the
treatment of Instent Restenosis. (May 03 )
• A multicenter randomized trial of drug eluting stent with ABT 278 in patients with DeNovo lesion. (Apr.
04.)
Carotid/Peripheral Research:
• Evaluate the safety and feasibility of Carotid artery stenting using Wallstent and Neurishield as cerebral
protection system. ( Nov. 2000 )
• Two different studies for carotid angioplasty stenting – free of emboli, using PurcuSurge Guirdewire Plus
Occlusion Balloon.( May .2000 )
5. • Evaluate the safety and feasibility and compare the carotid revascularization with PTCA/stent versus
Endarterectomy.( March 2001 )
• Evaluate the safety and feasibility of peripheral arteries (Femoral) ptca/stenting followed by Radiation
therapy to prevent restenosis. (Oct. 2000 )
• Determine the safety and feasibility of the Endotex Carotid Stent System in the treatment of extracranial
carotid artery lesions in symptomatic and asymptomatic patients.( Mrach 2000 ).
• To demonstrate the anticoagulation with Bivalirudine results in fewer major bleeding complications
compared with Unfractionated Heparin (UFH) in subject undergoing peripheral Endovascular
Intervention.
6. • Evaluate the safety and feasibility and compare the carotid revascularization with PTCA/stent versus
Endarterectomy.( March 2001 )
• Evaluate the safety and feasibility of peripheral arteries (Femoral) ptca/stenting followed by Radiation
therapy to prevent restenosis. (Oct. 2000 )
• Determine the safety and feasibility of the Endotex Carotid Stent System in the treatment of extracranial
carotid artery lesions in symptomatic and asymptomatic patients.( Mrach 2000 ).
• To demonstrate the anticoagulation with Bivalirudine results in fewer major bleeding complications
compared with Unfractionated Heparin (UFH) in subject undergoing peripheral Endovascular
Intervention.
