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

Running, not enrolling · Phase 3

Conditions studied: In-Stent Restenosis

In brief

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.

Key facts

Study ID

NCT06492174

Run by

Boston Scientific Corporation

People needed

20

Starts

2024-10-07

Expected to finish

2027-12-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Carondelet Medical Group St. Mary's Hospital — Tucson, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• Lindner Center for Research and Education at Christ Hospital — Cincinnati, Ohio, United States
• UPMC Pinnacle Health — Wormleysburg, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Centennial Medical Center — Nashville, Tennessee, United States
• Baylor Heart and Vascular Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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