Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease

Peking University Third Hospital1 site in 1 country1,000 target enrollmentJune 30, 2021

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Peking University Third Hospital
Enrollment: 1000
Locations: 1
Primary Endpoint: Number of Participants with Target lesion failure (TLF)
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.

Registry

clinicaltrials.gov

Start Date

June 30, 2021

End Date

June 30, 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University Third Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years old;
•Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction;
•Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1);
•Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm;
•Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%;
•Visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with NHLBI classification A, B, C type.
•If 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion.

Exclusion Criteria

•Main branch or branching target lesions require treatment with more than one device (DES or DCB);
•There is more than 1 non-target lesion requiring intervention on the target blood vessel;
•The distance between non-target lesion and target lesion is less than 10 mm;
•Main and branch lesions \> 26 mm or branch lesions length BBB\> mm;
•Left main lesion and its bifurcation lesion;
•Intra-stent restenosis or severe calcification;
•ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery;
•Severe heart failure (NYHA-IV or left ventricular ejection fraction \<35%);
•Cardiogenic shock;
•known to have renal failure (EGFR \<30ml/min/1.73m2);

Outcomes

Primary Outcomes

Number of Participants with Target lesion failure (TLF)

Time Frame: 12 months

Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization.

Number of Participants with net adverse clinical cardiovascular events (NACCE)

Time Frame: 12 months

Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding)

Secondary Outcomes

Technical success rate(1-2 days)
DAPT using time(1/6/12/24/36 month)
Clinical procedure time(during the procedure)
Number of Participants with ARC defines stent thrombosis(1/6/12/24/36 month)
Number of Participants with Bleeding events（BARC2, 3, and 5）(1/6/12/24/36 month)
Number of Participants with Target lesion failure (TLF)(1/6/24/36 month)
Number of Participants with Target vessel revascularization (TVR)(1/6/12/24/36 month)
Number of Participants with Target lesion revascularization (TLR)(1/6/12/24/36 month)