A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
- Conditions
- In-Stent Restenosis
- Interventions
- Device: PTCA balloon catheterDevice: AGENT DCB
- Registration Number
- NCT04647253
- Lead Sponsor
- Boston Scientific Corporation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Commercially available, PTCA Dilation Catheter PTCA balloon catheter - AGENT DCB AGENT DCB Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391).
- Primary Outcome Measures
Name Time Method Number of Participants With Target Lesion Failure 12-month The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
South Denver Cardiology
🇺🇸Littleton, Colorado, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Carondelet Medical Group St. Mary's Hospital
🇺🇸Tucson, Arizona, United States
St. Anthony Hospital
🇺🇸Lakewood, Colorado, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Lindner Center for Research and Education at Christ Hospital
🇺🇸Cincinnati, Ohio, United States
San Francisco Veterans Affairs Medical Center
🇺🇸San Francisco, California, United States
Overland Park Regional Medical Center
🇺🇸Overland Park, Kansas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Northside Hospital
🇺🇸Lawrenceville, Georgia, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Wake Medical Center
🇺🇸Raleigh, North Carolina, United States
UPMC Pinnacle Health
🇺🇸Wormleysburg, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
University of Washington
🇺🇸Seattle, Washington, United States
Bergan Cardiology
🇺🇸Omaha, Nebraska, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Methodist North Hospital
🇺🇸Memphis, Tennessee, United States
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Montefiore Medical Center
🇺🇸New York, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States