Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

Not Applicable

Withdrawn

• Conditions: Coronary Artery Restenosis; In-stent Coronary Artery Restenosis; In-stent Restenosis
• Interventions: Device: Plain old balloon angioplasty (POBA); Device: SeQuent Please ReX

• Registration Number: NCT05093244
• Lead Sponsor: B. Braun Medical Inc.

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.

Study Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-26
• Status Verified: 2023-02
• Study Start: 2023-02-10
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:

1. Dissection type C - F
2. TIMI < III
3. Residual stenosis >30%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain old balloon angioplasty (POBA)	Plain old balloon angioplasty (POBA)	-
SeQuent Please ReX	SeQuent Please ReX	Drug coated balloon (DCB) catheter.

Primary Outcome Measures

Name	Time	Method
Freedom from target lesion failure (TLF)	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 Outcome Measures

Name	Time	Method
Late lumen loss (LLL)	9 months post-procedure	Assessed on the first 100 subjects reaching 9-month follow-up (angiographic cohort). Minimum lumen diameter (MLD) assessed at follow-up angiography minus the MLD assessed immediately after the index procedure. MLDs are measured by qualitative comparative analysis.
Myocardial infarction (MI)	12 months post-procedure and annually thereafter to study completion	Not clearly attributable to a nontarget vessel
All death	12 months post-procedure and annually thereafter to study completion	Death of subject.
Device, lesion, and procedural success	Post-procedure (device and lesion success) and at discharge (procedural success)	Device success defined as achievement of a final residual stenosis of ≤30% (as determined by the angiographic core lab), using the SeQuent Please ReX or control balloon. Lesion success defined as achievement of a final residual stenosis of ≤0% (as determined by the angiographic core lab), using any device. Procedural success defined as lesion success without the occurrence of major adverse events during the procedure, where "major adverse event" is considered to be an event without the occurrence of in-hospital MI, TVR, or cardiac death.
Cardiovascular death	12 months post-procedure and annually thereafter to study completion	Death resulting from cardiovascular causes.
Major adverse cardiac events (MACE)	12 months post-procedure and annually thereafter to study completion	Defined as the composite of all death, clinically-driven TLR, and MI
Clinically-driven target lesion revascularization (TLR)	12 months post-procedure and annually thereafter to study completion	Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Stent thrombosis	12 months post-procedure and annually thereafter to study completion	Early, late, or very late; ARC category of definite or probable
Clinically-driven target vessel revascularization (TVR)	12 months post-procedure and annually thereafter to study completion	Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.