A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
Public ClinicalTrials.gov record NCT04647253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04647253
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 11, 2021 (Actual)
- Primary completion
- Oct 2, 2023 (Actual)
- Completion
- Sep 2027 (Estimated)
- Last update posted
- Sep 18, 2026
2021 – 2027
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Carondelet Medical Group St. Mary's Hospital | Tucson | Arizona | 85745 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| St. Anthony Hospital | Lakewood | Colorado | 80216 | — |
| South Denver Cardiology | Littleton | Colorado | 80210 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Northside Hospital | Lawrenceville | Georgia | 30046 | — |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | — |
| Evanston Hospital | Evanston | Illinois | 60201 | — |
| Overland Park Regional Medical Center | Overland Park | Kansas | 66211 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Bergan Cardiology | Omaha | Nebraska | 68124 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Montefiore Medical Center | New York | New York | 10467 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Wake Medical Center | Raleigh | North Carolina | 27610 | — |
| Lindner Center for Research and Education at Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| UPMC Pinnacle Health | Wormleysburg | Pennsylvania | 17053 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Methodist North Hospital | Memphis | Tennessee | 38104 | — |
| Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| Heart Hospital of Austin | Austin | Texas | 78756 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04647253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04647253 live on ClinicalTrials.gov.