A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
Running, not enrolling · Phase 3
Conditions studied: In-Stent Restenosis
In brief
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.
Key facts
- Study ID
- NCT04647253
- Run by
- Boston Scientific Corporation
- People needed
- 600
- Starts
- 2021-05-11
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Carondelet Medical Group St. Mary's Hospital — Tucson, Arizona, United States
- University of California San Diego — La Jolla, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
- Stanford University Medical Center — Stanford, California, United States
- St. Anthony Hospital — Lakewood, Colorado, United States
- South Denver Cardiology — Littleton, Colorado, United States
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Northside Hospital — Lawrenceville, Georgia, United States
- Wellstar Kennestone Hospital — Marietta, Georgia, United States
- Evanston Hospital — Evanston, Illinois, United States
- Overland Park Regional Medical Center — Overland Park, Kansas, United States
- Ochsner Medical Center — New Orleans, Louisiana, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Regions Hospital — Saint Paul, Minnesota, United States
- St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- Bergan Cardiology — Omaha, Nebraska, United States
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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