Clinical Trial

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

Study acronym: AGENT IDE
Active, Not Recruiting Phase 3
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Summary
The purpose of the AGENT IDE study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 36 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
Protocol Amendment History 25 amendments
This ClinicalTrials.gov record has been amended 25 times since 2024-07-01; most recent amendment 2026-07-15.
Status change: Recruiting → Active, Not Recruiting 2025-01-06
Status change: Not Yet Recruiting → Recruiting 2024-09-30
Trial Details
NCT Number NCT06492174
Lead Sponsor Boston Scientific Corporation
Conditions In-Stent Restenosis
Enrollment 20 participants
Start Date 2024-10-07
Primary Completion 2025-12-19 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-16