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NCT04647253 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
A Phase 3 study of In-Stent Restenosis, sponsored by Boston Scientific Corporation.
- Active
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT04647253 is a Phase 3 study of In-Stent Restenosis that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 600 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT04647253, a Phase 3 study of In-Stent Restenosis, is active but no longer recruiting, sponsored by Boston Scientific Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE AGENT DCB
- DEVICE PTCA balloon catheter
Study Locations (20)
California
- University of California San Diego - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- San Francisco Veterans Affairs Medical Center - San Francisco
- Stanford University Medical Center - Stanford
Massachusetts
- Tufts Medical Center - Boston
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Georgia
- Emory University Hospital - Atlanta
- Northside Hospital - Lawrenceville
- Wellstar Kennestone Hospital - Marietta
Colorado
- St. Anthony Hospital - Lakewood
- South Denver Cardiology - Littleton
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Carondelet Medical Group St. Mary's Hospital - Tucson
Florida
- Tallahassee Memorial Hospital - Tallahassee
Illinois
- Evanston Hospital - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2021-05-11 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04647253
The ClinicalTrials.gov registry entry for NCT04647253 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with In-Stent Restenosis appearing as the primary indexed condition, and to 2 interventions - of which AGENT DCB is the first listed.
NCT04647253 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Massachusetts, Georgia.
Frequently Asked Questions
What is clinical trial NCT04647253 about?
NCT04647253 is a clinical study titled "A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)". 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 o...
What is the current status of trial NCT04647253?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2021-05-11. Estimated completion is 2027-09.
What conditions does trial NCT04647253 study?
This clinical trial studies the following conditions: In-Stent Restenosis.
What interventions are being tested in trial NCT04647253?
The interventions under investigation include: AGENT DCB (DEVICE), PTCA balloon catheter (DEVICE).
Who is sponsoring clinical trial NCT04647253?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04647253 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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