This document summarizes a clinical case where a VascuTrak PTA Dilatation Catheter and Crosser CTO Recanalization Catheter were used to successfully treat a patient with critical limb ischemia and a chronic total occlusion in the anterior tibial artery. Specifically: 1) The patient presented with a chronic total occlusion in their anterior tibial artery and critical limb ischemia. 2) A Crosser CTO Catheter was used to cross the occlusion, followed by a VascuTrak Catheter to dilate the artery without needing stent placement. 3) Intravascular ultrasound confirmed the dilatation restored blood flow without complications like dissection. The procedure saved the patient's limb without

1. VascuTrak®
PTA Dilatation Catheter
CLINICAL CASE REPORT
Neil E. Strickman, MD and Federico E. Azpurua-Gil, MD
Texas Heart Institute / St. Luke’s Hospital, Houston Texas
VascuTrak® PTA Dilatation Catheter and
Crosser® CTO Recanalization Catheter
Successfully Relieved CTO of the Anterior Tibial Artery
Overview
This patient is a 47-year-old Hispanic male with a medical history including end-stage
renal disease on dialysis, diabetes mellitus, hypertension, coronary artery
disease, peripheral arterial disease and a below the knee amputation (BKA) years
earlier. Previously, he had undergone PTA/stenting of the left popliteal artery
with a self-expanding nitinol stent but the exact date remains unclear. He was
admitted to the hospital with left leg critical limb ischemia (CLI), osteomyelitis
and a non-healing ulcer of that foot.
On physical examination, he had palpable left femoral and popliteal pulses but
no palpable pedal pulses. A large ischemic ulcer was present in the lateral plantar
surface of the foot with necrotic tissue.
Angiography revealed patent left iliac, femoral, superficial femoral (SFA) and
popliteal arteries with minimal atherosclerotic disease. The popliteal stent had
minor restenosis. The posterior tibial (PT) artery was 100% occluded proximally;
the peroneal artery (P) was diffusely diseased distally while the anterior tibial
artery (AT) displayed a short 4 cm chronic total occlusion (CTO) in its mid
segment with distal reconstitution of flow through collaterals to the dorsalis pedis
(DP) artery (Figure 1). The DP artery was patent with filling from the AT antegrade.
Potential Treatment Strategy
This patient presented with left leg CLI and angiograms which showed the only
arterial vessel in the foot to be the DP, which filled from the AT. The PT and
peroneal arteries are diffusely diseased with only limited flow distally. There is
a short CTO at the mid segment of the AT. Based on these findings it appeared
the only way to save the leg/foot was to open the CTO
of the AT allowing more blood to flow distally to the foot.
A Crosser® Catheter 14S was selected to cross the CTO,
followed by Intravascular Ultrasound (IVUS) to document
exact lumen size to aid in achieving a satisfactory lumen
without the implantation of a stent. This was followed
by balloon angioplasty. The VascuTrak® Catheter allowed
us to use low inflation pressures to fracture the plaque
and allowed for more controlled, less damaging inflation
compared to standard PTA.1
Procedural Steps
An antegrade approach was preferred in this case due
to contralateral disease and acute angle of the aortoiliac
bifurcation. A 5F/45 cm sheath was introduced into the
left common femoral artery and advanced to the distal
left SFA. A hydrophobic 300 cm 0.014" wire was inserted
into a 4Fr Glide™ catheter, both of which were advanced
proximal to the AT total occlusion. This 4 cm CTO lesion
was then traversed using the Crosser® Catheter 14S
with subsequent advancement of the wire distal to the
occlusion. After the device was removed a monorail
Volcano Eagle Eye™ Platinum .014" digital IVUS catheter
confirmed the wire’s intraluminal position as well as the
vessel’s diameter and size (Figure 3).
Figure 2.
AT post-recanalization with
a Crosser® Catheter and
post-dilatation with a VascuTrak®
Catheter.
Figure 1.
Total occlusion of AT
Area 1
Area: 2.8mm2
Max. Diam: 2.2mm
Min. Diam: 1.6mm
Difference
9.5mm2 (77.1%)
Area 2
Area: 12.3mm2
Max. Diam: 4.3mm
Min. Diam: 3.5mm
Area 1
Area: 5.9mm2
Max. Diam: 2.9mm
Min. Diam: 2.6mm
Figure 3.
IVUS post-recanalization with a Crosser® Catheter
Figure 4.
IVUS post-dilatation with a VascuTrak® Catheter

2. VascuTrak® PTA Dilatation Catheter
Indications for Use: The VascuTrak® PTA Dilatation Catheter is intended to dilate
stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries
and for the treatment of obstructive lesions of native or synthetic arterioveneous
dialysis fistulae. This device is also recommended for post dilatation of balloon
expandable stents, self-expanding stents, and stent grafts in the peripheral
vasculature.
Contraindications: The VascuTrak® PTA Dilatation Catheter is contraindicated:
1) where there is the inability to cross the target lesion with a guidewire;
2) for use in the coronary or neuro vasculature.
Warnings: 1) Contents supplied sterile using ethylene oxide (EO). Non-pyrogenic.
Do not use if sterile barrier is opened or damaged. Do not reuse, reprocess or
re-sterilize. Use the catheter prior to the “Use By” date specified on the package
label. 2) This device has been designed for single use only. Reusing this medical
device bears the risk of cross-patient contamination as medical devices – particularly
those with long and small lumina, joints and/or crevices between components – are
difficult or impossible to clean once body fluids or tissues with potential pyrogenic
or microbial contamination have had contact with the medical device for an
indeterminable period of time. The residue of biological material can promote the
contamination of the device with pyrogens or microorganisms, which may lead to
infectious complications. 3) Do not resterilize. After resterilization, the sterility of
the product is not guaranteed because of an indeterminable degree of potential
pyrogenic or microbial contamination, which may lead to infectious complications.
Cleaning, reprocessing and/or resterilization of the present medical device increases
the probability that the device will malfunction due to potential adverse effects on
components that are influenced by thermal and/or mechanical changes.
4) To reduce the potential for vessel damage, the inflated diameter and length of
the balloon should approximate the diameter and length of the vessel just proximal
and distal to the stenosis. 5) When the catheter is exposed to the vascular system,
it should be manipulated while under high-quality fluoroscopic observation. Do not
advance or retract the catheter unless the balloon is fully deflated. If resistance is
met during manipulation, determine the cause of the resistance before proceeding.
Applying excessive force to the catheter can result in tip breakage or balloon
separation. 6) Do not exceed the RBP recommended for this device. Balloon rupture
may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a
pressure monitoring device is recommended. 7) After use, this product may be a
potential biohazard. Handle and dispose of in accordance with acceptable medical
practices and applicable local, state and federal laws and regulations.
Precautions: 1) Carefully inspect the catheter prior to use to verify that catheter
has not been damaged during shipment and that its size, shape and condition are
suitable for the procedure for which it is to be used. Do not use if product damage
is evident. 2) The VascuTrak® PTA Dilatation Catheter should only be used by
physicians trained in the performance of percutaneous transluminal angioplasty.
3) In order to activate the hydrophilic coating, wet the VascuTrak® balloon and
catheter with sterile saline or wipe the balloon catheter with sterile saline saturated
gauze immediately prior to its insertion in the body. Do not wipe the balloon catheter
with dry gauze. 4) When backloading the catheter onto the guidewire, support the
catheter and ensure that the guidewire tip does not snag or come into contact with
the balloon. 5) The minimal acceptable sheath French size is printed on the package
label. Do not attempt to pass the PTA catheter through a smaller size introducer
sheath than indicated on the label. 6) Use the recommended balloon inflation
medium (50% contrast medium/50% sterile saline solution). It has been shown that
a 25/75% contrast/saline ratio has yielded faster balloon inflation/deflation times.
Never use air or other gaseous medium to inflate the balloon. 7) VascuTrak® PTA
Dilatation Catheters should be used with caution for procedures involving calcified
lesions or synthetic vascular grafts due to the abrasive nature of these lesions.
8) Never attempt to move the guidewire when the balloon is inflated.
9) Fully evacuate the balloon prior to withdrawing the system. Larger sizes of
VascuTrak® balloons may exhibit slower deflation times. If the balloon does not
deflate, advance a sheath or catheter over the proximal portion of the balloon to
straighten out the transition from connection of the balloon to the inflation lumen.
10) If resistance is felt during post-procedure withdrawal of the catheter through
the introducer sheath, determine if contrast medium is trapped in the balloon
with fluoroscopy. If contrast is present, push the balloon out of the sheath and
then completely evacuate the contrast before proceeding to withdraw the balloon.
11) If resistance is still felt during post-procedure withdrawal of the catheter, it is
recommended to remove the balloon catheter and guidewire/ introducer sheath as
a single unit. 12) Do not continue to use the balloon catheter if the shaft has been
bent or kinked. 13) Prior to re-insertion through the introducer sheath, re-activate the
hydrophilic coating and clean the balloon catheter by wiping the balloon catheter with
sterile saline saturated gauze and rinsing with sterile saline. Do not wipe the balloon
catheter with dry gauze.
Potential Adverse Reactions: The complications that may result from a peripheral
balloon dilatation procedure include: • Additional intervention • Allergic reaction to
drugs or contrast medium • Aneurysm or pseudoaneurysm • Arrhythmias
• Embolization • Hematoma • Hemorrhage, including bleeding at the puncture site
• Hypotension/hypertension • Inflammation • Occlusion • Pain or tenderness
• Pneumothorax or hemothorax • Sepsis/infection • Shock • Short-term hemodynamic
deterioration • Stroke • Thrombosis • Vessel dissection, perforation, rupture or spasm.
Please consult product labels and package inserts for indications,
contraindications, hazards, warnings, cautions, and information for use.
The opinions and clinical experiences presented herein are for informational purposes
only. The results from this case study may not be predictive for all patients. Individual
results may vary depending on a variety of patient specific attributes. The physician
has been compensated by Bard Peripheral Vascular, Inc. for the time and effort in
preparing the above case study for Bard’s further use and distribution.
Bard, Crosser and VascuTrak are trademarks and/or registered trademarks of
C. R. Bard, Inc. All other trademakes are the property of their respective owners.
Copyright ® 2012, C. R. Bard, Inc. All Rights Reserved.
S120201 Rev 0
Bard Peripheral Vascular, Inc.
1625 W. 3rd Street Tempe, AZ 85281 USA
Tel: 1 480 894 9515 / 1 800 321 4254
Fax: 1 480 966 7062 / 1 800 440 5376
www.bardpv.com
After removal of the IVUS catheter, a 3.5 mm x 40 mm
VascuTrak® Catheter was advanced into the AT and inflated
gradually over 2 minutes to 6 atmospheres at the site of
occlusion. The balloon was held at 6 atmospheres for 4 minutes
and then deflated and removed. Post interventional IVUS and
angiographic results showed no significant residual stenosis or
dissection (Figures 2 and 4).
Keys to Success
• The use of the Crosser® Catheter and VascuTrak® Catheter in
this location provides an alternate approach to stenting, which
has not been shown to have long-term benefits regarding
continued patency.
• Gradual inflation of the VascuTrak® Catheter has continued to
yield excellent results with respect to flow-limiting dissection
occurrence.
• The VascuTrak® Catheter minimized the expansion of the
vessel. This can reduce elastic recoil and injury to the vessel
and result in greater luminal gain.1
Discussion of Interventional Report
This patient had a CTO of the AT in the setting of CLI with the
AT being the only remaining vessel supplying the viable foot.
With use of the Crosser® CTO Catheter, the anterior tibial arterial
CTO was crossed without any significant difficulties of remaining
intraluminal. Subsequently, a single, slow and prolonged inflation
with an appropriately sized VascuTrak® Catheter created a wide
lumen without dissection or perforations, improving distal
perfusion without the need for stenting. IVUS imaging was useful
in selecting size and length of the balloon, which is paramount to
avoid dissections or perforations.
Conclusion
When faced with opening the only vessel remaining to an
actively ischemic leg/foot, one needs to use the tools and
equipment readily available. Appropriate usage of the Crosser®
CTO Catheter and VascuTrak® Catheter can help address difficult
revascularization needs.
References
1. Based on Finite Element Analysis. Data on file.
The Crosser® CTO Recanalization Catheter
Indications: The Crosser® Recanalization System is indicated to facilitate the
intra-luminal placement of conventional guidewires beyond peripheral artery
chronic total occlusions via atherectomy. The Crosser® Catheter is only intended
for use with the Crosser® Generator. Refer to the Crosser® Generator Manual of
Operations for proper use.
Contraindications: The device is contraindicated for use in carotid arteries.
Warnings and Precautions
• The Crosser® Recanalization System should only be used by individuals trained
in percutaneous transluminal angioplasty (PTA or PTCA).
• Prior to use, the packaging and product should be inspected for signs of
damage. Never use damaged product or product from a damaged package.
• DO NOT activate the Crosser® Recanalization System without proper irrigation.
Make sure to establish proper irrigation prior to introduction into guide catheter.
Always use REFRIGERATED SALINE.
• The Crosser® Recanalization System should be used in conjunction with proper
anticoagulation agents.
• Never advance or withdraw the Crosser® Catheter without proper fluoroscopic
guidance.
• It is not recommended to use the Crosser® Catheter over wires which have
polymer-jacketed distal ends.
• Do not exceed 5 minutes of activation time as Crosser® Catheter malfunction
may occur. If 5 minutes of activation time is achieved exchange for a second
Crosser® Catheter before resetting the Crosser® Generator.
• When using the Crosser® Catheter 14S or 14P with the MicroSheath®
XL Support Catheter Tapered, the Crosser® Catheter can be advanced
approximately 15 cm from the tip before resistance is encountered due to the
taper on the Crosser® Catheter aligning with the taper on the support catheter.
A femoral marker is located 120cm from the distal tip of the Crosser® Catheter.
The femoral marker can be used as an indicator that the tapers on the
catheters are nearing alignment; advance the Crosser® Catheter slowly. Do not
continue to advance the Crosser® Catheter if resistance is encountered. Refer
to the table below for each specific support catheter, the Crosser® Catheter
that it is used with, and how far the Crosser® Catheter can be advanced before
resistance occurs.
• When manipulating the Crosser® Catheter, the Catheter shaft may become
warm to the touch. A warm feeling is normal, however, if the Catheter shaft
becomes hot discontinue use immediately and withdraw from patient. Once
removed from the patient confirm that irrigation is flowing.
• When using the Crosser® Catheter in tortuous anatomy, the use of a support
catheter is recommended to prevent kinking or prolapse of the Crosser®
Catheter tip. Kinking or prolapse of the tip could cause catheter breakage and/
or malfunction.
• Position Foot Switch and cable to minimize potential tripping hazard.
• Ensure Crosser® Generator is securely mounted to IV pole to reduce risk of
falling.
• Should high frequency vibration fail to stop when foot switch is released, power
off Crosser® Generator or unplug from power receptacle.
• Never activate the Crosser® Generator without a Crosser® Catheter attached to
the Transducer.
• The Crosser® Catheter is designed and intended for single patient use only.
DO NOT resterilize and/or reuse it.
Adverse Effects: As with most percutaneous interventions, potential adverse
effects include: Bleeding which may require transfusion or surgical intervention
• Hematoma • Perforation • Dissection • Guidewire entrapment and/or fracture
• Hypertension / Hypotension • Infection or fever • Allergic reaction
• Pseudoaneurysm or fistula Aneurysm • Acute reclosure • Thrombosis
• Ischemic events • Distal embolization • Excessive contrast load resulting in renal
insufficiency or failure • Excessive exposure to radiation • Stroke/CVA • Restenosis
• Repeat catheterization / angioplasty • Peripheral artery bypass • Amputation
• Death or other bleeding complications at access site.
Please consult product labels and package inserts for indications,
contraindications, hazards, warnings, cautions and instructions for use.
VascuTrak®
PTA Dilatation Catheter
VascuTrak®
PTA Dilatation Catheter
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