Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

Official Title

AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

Keywords

In-Stent Restenosis, Drug coated balloon, AGENT DCB, PTCA balloon catheter, Commercially available, PTCA Dilation Catheter

Eligibility

Locations

  • San Francisco Veterans Affairs Medical Center
    San Francisco California 94121 United States
  • Stanford University Medical Center
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT04647253
Phase
Phase 3 In-Stent Restenosis Research Study
Study Type
Interventional
Participants
About 600 people participating
Last Updated