A Prospective, Randomized, Multi-center IDE Study to Assess the SeQuent Please ReX Drug Coated PTCA Balloon Catheter for the Treatment of In-stent Restenosis (RESPECT-ISR)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- In-stent Coronary Artery Restenosis
- Sponsor
- B. Braun Medical Inc.
- Primary Endpoint
- Freedom from target lesion failure (TLF)
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated.
Detailed Description
The investigation is a prospective, randomized, multi-center IDE study comparing the SeQuent Please ReX to plain old balloon angioplasty (POBA). The study will be conducted at up to 30 investigational sites and enroll up to 296 patients with in-stent restenosis of a metallic coronary stent who are suitable candidates for PTCA procedures. After consent and assessment of inclusion and exclusion criteria, eligible patients will be randomized to either the SeQuent Please ReX or POBA arm based on a 2:1 randomization ratio. Subjects will return for follow-up through 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:
- •Dissection type C - F
- •TIMI \< III
- •Residual stenosis \>30%
Outcomes
Primary Outcomes
Freedom from target lesion failure (TLF)
Time Frame: 12 months post-procedure
TLF is defined as the composite of any of the following events: * Clinically-driven target lesion revascularization (TLR) * Myocardial infarction (MI; not clearly attributable to a nontarget vessel) * Cardiovascular death
Secondary Outcomes
- Late lumen loss (LLL)(9 months post-procedure)
- Myocardial infarction (MI)(12 months post-procedure and annually thereafter to study completion)
- All death(12 months post-procedure and annually thereafter to study completion)
- Device, lesion, and procedural success(Post-procedure (device and lesion success) and at discharge (procedural success))
- Cardiovascular death(12 months post-procedure and annually thereafter to study completion)
- Major adverse cardiac events (MACE)(12 months post-procedure and annually thereafter to study completion)
- Clinically-driven target lesion revascularization (TLR)(12 months post-procedure and annually thereafter to study completion)
- Stent thrombosis(12 months post-procedure and annually thereafter to study completion)
- Clinically-driven target vessel revascularization (TVR)(12 months post-procedure and annually thereafter to study completion)