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Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

NCT05846893 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1436

Last updated 2024-11-05

No results posted yet for this study

Summary

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

Conditions

Interventions

DEVICE

SeQuent® Please NEO drug-coated balloon catheter

Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries

DEVICE

Current-generation drug-eluting stent

Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries

Sponsors & Collaborators

  • B. Braun Melsungen AG

    collaborator INDUSTRY

  • Ulsan University Hospital

    collaborator OTHER

  • European Cardiovascular Research Center

    collaborator NETWORK

  • Seoul National University Hospital

    collaborator OTHER

  • Universität des Saarlandes

    collaborator OTHER

  • B. Braun Medical Industries Sdn. Bhd.

    lead INDUSTRY

Principal Investigators

  • Eun-Seok Shin, MD, Ph.D · Ulsan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2026-10-31
Completion
2028-09-30

Countries

  • Malaysia
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT05846893 on ClinicalTrials.gov