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Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment — RESPECT-ISR  

In-stent Restenosis Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05093244
Study type Interventional
Source B. Braun Medical Inc.
Contact
Status Withdrawn
Phase N/A
Start date February 10, 2023
Completion date February 10, 2023
View Details
See also
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