A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
Active, not recruiting · Phase 3 · NCT04647253
Conditions: In-Stent Restenosis
At a glance
- Research payments reported, 2025
- $736,754
- U.S. investigators named
- 41
- Sites paid
- 39
- Planned or actual enrollment
- 600
About the trial
- Sponsor
- Boston Scientific Corporation
- Tested
- AGENT DCB (device), PTCA balloon catheter (device)
- Dates
- Started 2021-05-11; completion 2027-09
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-11-02. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Boston Scientific Corporation reported $736,754 in research payments for this study in 2025 (324 payments).
Products named: Clinical Trial Product
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Mustafa I. Ahmed, M.D. Cardiology · Birmingham, AL
- Kapildeo Lotun, M.D. Interventional Cardiology · Tucson, AZ
- Lawrence W. Ang, M.D. Interventional Cardiology · San Diego, CA
- Suhail Y. Dohad, M.D. Interventional Cardiology · Beverly Hills, CA
- Kendrick Shunk, M.D. Interventional Cardiology · San Francisco, CA
- Jennifer A. Tremmel, MD Interventional Cardiology · Stanford, CA
- John D. Altman, MD Cardiology · Lakewood, CO
- Cinthia T. Bateman, M.D. Interventional Cardiology · Littleton, CO
- William C. Dixon IV Interventional Cardiology · Tallahassee, FL
- Cindy L. Grines, M.D. Cardiology · Atlanta, GA
- William J. Nicholson, MD Interventional Cardiology · Atlanta, GA
- Arthur B. Reitman, M.D. Interventional Cardiology · Marietta, GA
- Justin P. Levisay Interventional Cardiology · Evanston, IL
- Rajendran Sabapathy, MD Interventional Cardiology · Overland Park, KS
- Jose D. Tafur Soto, MD Interventional Cardiology · New Orleans, LA
- Kevin J. Croce, MD, PHD Cardiology · Chestnut Hill, MA
- Farouc A. Jaffer, MD PHD Interventional Cardiology · Boston, MA
- Carey Kimmelstiel, MD Cardiology · Boston, MA
- Robert W. Yeh, MD Interventional Cardiology · Boston, MA
- Khaldoon Alaswad, MD Interventional Cardiology · Detroit, MI
- Johannes Brechtken, M.D. Cardiology · Saint Paul, MN
- James A. Grantham, MD Interventional Cardiology · Kansas City, MO
- Damien M. Marycz, M.D. Interventional Cardiology · Raleigh, NC
- Himanshu Agarwal, MD Interventional Cardiology · Omaha, NE
- Matthew D. Saybolt, M.D. Interventional Cardiology · Eatontown, NJ
- Michael B. Collins, M.D. Interventional Cardiology · New York, NY
- Mohamed Azeem Latib, MD Interventional Cardiology · Bronx, NY
- Jeffrey W. Moses, M.D. Interventional Cardiology · New York, NY
- Richard A. Shlofmitz, M.D. Interventional Cardiology · Roslyn, NY
- Amar Krishnaswamy, M.D. Interventional Cardiology · Cleveland, OH
- Steven G. Rudick Interventional Cardiology · Cincinnati, OH
- William B. Bachinsky, MD Cardiology · Mechanicsburg, PA
- Jinnette D. Abbott, MD Interventional Cardiology · Providence, RI
- Claro F. Diaz, MD Interventional Cardiology · Memphis, TN
- Brian K. Jefferson, MD Interventional Cardiology · Nashville, TN
- Alpesh R. Shah, M.D. Interventional Cardiology · Pearland, TX
- Robert Stoler, M.D. Interventional Cardiology · Dallas, TX
- Francis J. Zidar, MD Interventional Cardiology · Austin, TX
- Angela M. Taylor, M.D. Interventional Cardiology · Charlottesville, VA
- Behnam N. Tehrani, M.D. Cardiology · Falls Church, VA
- Kathleen E. Kearney, M.D Interventional Cardiology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Trustees of Columbia Univ in The City of Ny $102,287
- HCA Research Institute LLC $78,323
- St Francis Research and Educational Corporation Inc $70,105
- Baylor Research Institute $51,621
- Cedars-Sinai Medical Center, CA $44,018
- St Lukes Hospital of Kansas City, MO $37,271
- Massachusetts General Hospital, MA $35,733
- Cleveland Clinic, OH $31,195
- The Regents of University of California $28,546
- Pinnaclehealth Cardiovascular Institute $23,800
- Emory University Hospital, GA $21,876
- Beth Israel Deaconess Medical Center, MA $18,824
- Biomedical Research Alliance of New York $17,550
- University of Washington Medical Ctr, WA $15,535
- Methodist Hospital $15,389
- The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital $14,069
- Colorado Heart and Vascular PC $13,427
- Lebonheur Childrens Hospital $12,386
- University of Alabama Hospital, AL $11,388
- Smsj Tucson Holdings LLC $10,139
- St Davids Heart & Vascular PLLC $9,261
- Brigham and Women's Hospital, MA $7,403
- Henry Ford Health Hospital, MI $6,697
- Portercare Adventist Health System $5,689
- Rhode Island Hospital, RI $5,662
- Inova Loudoun Hospital, VA $5,222
- Northshore University Healthsystem - Evanston Hospital, IL $5,044
- Northside Hospital Gwinnett, GA $4,892
- Wakemed, Raleigh Campus, NC $4,524
- Tallahassee Research Institute Incorporated $4,191
- Tufts Medical Center, MA $3,913
- Midwest Heart and Vascular Specialists LLC $3,822
- Northern California Institute for Research and Education $3,689
- Ochsner Medical Center Acute, LA $3,398
- University of Virginia Medical Center, VA $2,875
- Hackensack Meridian Health Hackensack University Medical Center $2,861
- Wellstar Health System $1,974
- Alegent Creighton Clinic $1,478
- Healthpartners Institute $679
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.