Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of In-Stent Restenosis, sponsored by Boston Scientific Corporation.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What the registry record for NCT04647253 still lists
NCT04647253 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for In-Stent Restenosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04647253's enrollment target sits among peer trials
600 608th of 2000 higher than 1,364 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00004317 · 600 participants · Phase 4
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis
- NCT00209235 · 600 participants · NA
Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
- NCT01473784 · 600 participants · NA
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
- NCT01866371 · 600 participants
High Resolution Retinal Imaging
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI