This study evaluated the safety and efficacy of the novel Svelte Acrobat Integrated Delivery System (IDS) for percutaneous coronary interventions (PCI) via a radial approach using 5-French catheters. The study enrolled 55 patients and found a primary endpoint success rate of 91%, defined as direct stent implantation without need for post-dilation. Secondary endpoints including procedural success rates were also high. The study concluded the IDS system allows for safe and effective PCI via the radial approach in select patient populations and can reduce costs compared to traditional systems by an estimated $300 per procedure.

1. Evaluation of the Safety and Efficacy of the Novel
Svelte Acrobat Integrated Delivery System via a
Radial Approach with 5-French Catheters
Carlos Eduardo Faria Silva M.D.3,
1- Instituto Dante Pazzanese de Cardiologia, São Paulo, SP, Brazil;
2- Irmandade da Santa Casa de Misericórdia de Marília, Marília, SP, Brazil;
3- Hospital Padre Albino, FIPA, Catanduva, SP, Brazil;

2. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated
Delivery System via a Radial Approach with 5-French Catheters
We have no potential conflict of interest

3. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Introduction

4. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
The Svelte™ Acrobat Integrated Delivery System
(IDS)
A: Standard luer hub with loop clip for indeflator connection.
B: Integrated, adjustable torque device.
C: Uni-body construction with hydrophilic coating (145-mm length) and compatible with 5-French
catheters.
D: BCB (balloon control bands) technology to minimize edge delivery and to facilitate re-wrap.
E: Low-compliant nylon balloon; Nominal pressure 10–12 atmospheres, rated burst pressure 18
atmospheres.
F: L605 cobalt chromium stent (81 μm strut thickness); 0.029" (0.74 mm) crimped profile.
G: A 0.012" platinum-iridium atraumatic flexible coil wire tip.

5. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Methods
Patient selection
 Prospective, multicenter (3), non-randomized, single-arm study
evaluated patients with CAD who were candidates for elective PCI
with the Svelte Acrobat IDS via a radial approach with 5-French
guiding catheters.
 The study protocol was approved by independent Ethics
Committee at each participant research-related institutions in
accordance with the Declaration of Helsinki for Human Research.
All patients read and signed the informed consent.

6. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Primary End-point
• The primary end point was IDS success via a radial approach with 5-
French catheters, which was defined as DS without requirement of
post-dilatation with additional balloon catheters and achievement of
TIMI 3 flow and residual stenosis <20% as determined by QCA.
Second End-point
• DS success of the target lesion; Stent success with or without pre-dilatation;
Procedure success; Incidence of bleeding; Procedural
length and Fluoroscopy (min); Contrast used during procedure (mL);
Additional materials; MACE and MACE-free survival at 8 months.

7. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Inclusion criteria
 ≥18 years old;
 Stable angina, silent ischemia or unstable angina.
 Reference diameter of 2–3 mm and a target lesion with stenosis of 50–99%
(visual analysis) with ≤20 mm extension;
 agreement to participate in the study and provide informed consent (prior
to procedure) after the overall risks, goals and nature of the trial were
explained.
Exclusion criteria
 refusal or inability to sign the written informed consent;
 left ventricular ejection fraction ≤30%;
 in-stent restenosis;
 target lesion ≥50% in the unprotected left main artery;
 target lesion in bifurcation;
 excessive calcification;
 stent previously ( <10 mm from the target lesion); previous PCI <6 months or
scheduled within the next 30 days.

8. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Statistical Analysis
• A sample size of 50 patients was deemed sufficient for the initial
performance, safety and efficacy evaluation of the Svelte Acrobat device
with a reasonable distribution of clinical and angiographic variables related
to the procedure and materials in question.
• Statistical analysis was performed using Microsoft Office Excel 2007, version
12.0 (Microsoft Corp., Redmond, WA, USA).
Analysis of Procedural Costs
• In Brazil, the public health system generally provides reimbursement for
one PCI with the following materials: one guiding catheter, one guide wire,
one balloon catheter (which can be used for pre- or post-dilatation), and
one stent. Based on this, we simulated a matched analysis of the PCIs using
the Svelte Acrobat IDS in this study with the expected PCIs from the
Monorail system, as available in our public health system.

9. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters

10. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters

11. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Two Successful Svelte™ Acrobat
IDS Implantations – The direct
stent implantation in complex
lesions via the radial approach
(baseline and post-procedure).
Two Unsuccessful Svelte™ Acrobat IDS
Implantations – The direct stent
implantation in a distal lesion and a tortuous
vessel (baseline, IDS, pre-dilation, and post-procedure)

12. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters

13. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters

14. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Analysis of Procedural Costs
• In our study, the IDS success was 91%, and to perform the 55
PCIs, 55 guide catheters, 55 coronary integrated stent systems,
five additional guide wires, and five additional balloon catheters
(pre- and post-dilation) were necessary. To perform the 55 PCIs
using the traditional Monorail system, we expected to use at
least 55 guide catheters, 55 guide wires, 55 balloon catheters,
and 55 stents. Considering the values of reimbursement in our
country, $300 could be saved per procedure, which is about
20% of the total costs for each PCI performed in Brazil.

15. Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery
System via a Radial Approach with 5-French Catheters
Limitations
• Sample size.
• Randomized control group.
• Bare metal stents instead of drug-eluting stents.
Conclusion
• DS using the Svelte™ Acrobat IDS via a radial approach
with 5-French catheters is safe and efficacious in select
CAD patients, and it is associated with procedural cost
savings.