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RECRUITING 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

NCT06959524 · View on ClinicalTrials.gov ↗

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.

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

120 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,616 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06959524 reports 20 study locations spanning 12 distinct geographic areas — top geographies include New York, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06959524?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial