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Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment

NCT05093244 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-14

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Infraredx

    collaborator INDUSTRY

  • B. Braun Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Jorge Saucedo, MD, MBA · Froedtert & Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2023-02-10
Completion
2023-02-10
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05093244 on ClinicalTrials.gov