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The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT

NCT07162792 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-09

No results posted yet for this study

Summary

This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.

Conditions

  • Coronary Artery Disease(CAD)
  • de Novo Coronary Lesions

Interventions

DEVICE

bioresorbable scaffold

75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of BRS.

DEVICE

drug-coated balloon

75 subjects with de novo large vessel coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of DCB.

Sponsors & Collaborators

  • Xuzhou Third People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-23
Primary Completion
2027-12-30
Completion
2028-12-30

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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 NCT07162792 on ClinicalTrials.gov