A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) (NCT04647253)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Carondelet Medical Group St. Mary's Hospital — Tucson, Arizona
- University of California San Diego — La Jolla, California
- Cedars Sinai Medical Center — Los Angeles, California
- San Francisco Veterans Affairs Medical Center — San Francisco, California
- Stanford University Medical Center — Stanford, California
- St. Anthony Hospital — Lakewood, Colorado
- South Denver Cardiology — Littleton, Colorado
- Tallahassee Memorial Hospital — Tallahassee, Florida
- Emory University Hospital — Atlanta, Georgia
- Northside Hospital — Lawrenceville, Georgia
- Wellstar Kennestone Hospital — Marietta, Georgia
- Evanston Hospital — Evanston, Illinois
- Overland Park Regional Medical Center — Overland Park, Kansas
- Ochsner Medical Center — New Orleans, Louisiana
- Tufts Medical Center — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Henry Ford Hospital — Detroit, Michigan
- Regions Hospital — Saint Paul, Minnesota
- St. Luke's Hospital of Kansas City — Kansas City, Missouri
- Bergan Cardiology — Omaha, Nebraska
- Jersey Shore University Medical Center — Neptune City, New Jersey
- Columbia University Medical Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in In-Stent Restenosis
Explore by condition: All In-Stent Restenosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.