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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1616

Last updated 2026-05-07

No results posted yet for this 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

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

Interventions

DEVICE

Drug Eluting Balloon

AGENT DCB

DEVICE

Drug eluting stent

Any commercially available DES used for standard of care.

PROCEDURE

Plain old balloon angioplasty

Bifurcation side branch - POBA

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • David Kandzari · Piedmont Heart Institute

  • Margaret McEntegart · NYPH/CUIMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2028-03-31
Completion
2032-03-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • China
  • Germany
  • Ireland
  • New Zealand
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959524 on ClinicalTrials.gov