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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 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.

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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.

Conditions Studied

Coronary Arterial Disease (CAD) de Novo Lesions in Native Coronary Arteries

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

FieldValue
Enrollment Target 1,616 participants
Start Date 2025-08-21
Est. Completion 2032-03
Phase NA

Sponsor

Boston Scientific Corporation

280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06959524

The ClinicalTrials.gov registry entry for NCT06959524 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 1,616 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,756-participant average among 5 other Coronary Arterial Disease (CAD) trials with a reported enrollment target (41% lower). The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.