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NCT06959524 · ClinicalTrials.gov registry record · NA
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
A NA study of Coronary Arterial Disease (CAD) and de Novo Lesions in Native Coronary Arteries, sponsored by Boston Scientific Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 1,616
- Enrollment target
- 20
- Study locations
NCT06959524: Recruiting NA study of Coronary Arterial Disease (CAD) and de Novo Lesions in Native Coronary Arteries, sponsored by Boston Scientific Corporation.
NCT06959524 is a NA study of Coronary Arterial Disease (CAD) and de Novo Lesions in Native Coronary Arteries that is actively recruiting participants, run by Boston Scientific Corporation. The registered enrollment target is 1,616 participants, below the 2,756-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06959524, a NA study of Coronary Arterial Disease (CAD) and de Novo Lesions in Native Coronary Arteries, is actively recruiting participants, sponsored by Boston Scientific Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,616 participants
- Enrollment target
- 20
- Study locations
Study Summary
AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and/or balloon angioplasty in patients with de novo coronary lesions. Subjects must have a de novo target lesion located in a native coronary artery.
Primary Outcome
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. The MI events include the Peri-Procedural MI (PPMI) according to the SCAI MI definition and the spontaneous MI according to the 4th Universal MI definition.
Conditions Studied
Interventions
- DEVICE Drug Eluting Balloon
- DEVICE Drug eluting stent
- PROCEDURE Plain old balloon angioplasty
Study Locations (20)
New York
- Mount Sinai Medical Center - New York
- Columbia University Medical Center - New York
- St. Francis Hospital - Roslyn
- Montefiore Medical Center - The Bronx
Georgia
- Piedmont Hospital - Atlanta
- Emory University Hospital - Atlanta
- Wellstar Kennestone Hospital - Marietta
California
- USC Medical Center - Los Angeles
- Stanford University Medical Center - Stanford
Massachusetts
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Michigan
- Henry Ford Hospital - Detroit
- Corewell Health - Grand Rapids
Colorado
- South Denver Cardiology Associates, PC - Littleton
Florida
- The Cardiac and Vascular Institute Research Foundation - Gainesville
Illinois
- Endeavor Health - Glenview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,616 participants |
| Start Date | 2025-08-21 |
| Est. Completion | 2032-03 |
| Phase | NA |
What NCT06959524 shows while recruiting
NCT06959524 is an interventional study that assigns participants to a tested intervention. Its 1,616 participants enrollment target places it among the larger protocols in the corpus, below the 2,756-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (41% lower).
The record links to 2 conditions, with Coronary Arterial Disease (CAD) appearing as the primary indexed condition, and to 3 interventions - of which Drug Eluting Balloon is the first listed.
NCT06959524 names 20 study sites across 12 states, led by New York, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT06959524 about?
NCT06959524 is a clinical study titled "AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions". AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting ste...
What is the current status of trial NCT06959524?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,616 participants. The study started on 2025-08-21. Estimated completion is 2032-03.
What conditions does trial NCT06959524 study?
This clinical trial studies the following conditions: Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries.
What interventions are being tested in trial NCT06959524?
The interventions under investigation include: Drug Eluting Balloon (DEVICE), Drug eluting stent (DEVICE), Plain old balloon angioplasty (PROCEDURE).
Who is sponsoring clinical trial NCT06959524?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06959524 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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