NCT05093244

Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

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)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: B. Braun Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• In-stent Coronary Artery Restenosis
• Coronary Artery Restenosis
• In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	SeQuent Please ReX	The SeQuent Please ReX is a conventional rapid exchange balloon tip catheter with a drug-coated balloon (DCB). The surface of the SeQuent Please ReX balloon is coated with paclitaxel, embedded in a soluble matrix (resveratrol).
DEVICE	Plain old balloon angioplasty (POBA)	Any commercially available semi-compliant PTCA balloon may be used per the investigator's discretion.

Timeline

• Start date: 2023-02-10
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2021-10-26
• Last updated: 2023-02-14

Regulatory

• FDA-regulated device study