Clinical Trial

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

Study acronym: AGENT IDE
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 65 amendments
This ClinicalTrials.gov record has been amended 65 times since 2020-11-23; most recent amendment 2026-07-15.
Status change: Recruiting → Active, Not Recruiting 2022-09-13
Status change: Withheld → Recruiting 2021-05-14
Trial Details
NCT Number NCT04647253
Lead Sponsor Boston Scientific Corporation
Conditions In-Stent Restenosis
Enrollment 600 participants
Start Date 2021-05-11
Primary Completion 2023-10-02 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-17