The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05488665
• Lead Sponsor: Yonsei University

Brief Summary

In this COMPLETE randomized trial, using the contemporary second-generation drug-eluting stent, we aimed to test whether the crush technique is superior to the culotte technique for the treatment of bifurcation lesions in terms of 1-year target-lesion failure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-04
• Study Start: 2022-11-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2027-09-27
• Study Completion: 2028-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 512

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target lesion failure	1 year	The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Clinically driven target-lesion revascularization	1 year	a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Cardiovascular death	1 year	Death resulting from cardiovascular causes.
Target vessel myocardial infarction	1 year	The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.
Target-vessel or non-target vessel myocardial infarction	1 year	The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.
Definite or probable stent thrombosis	1 year	Stent thrombosis is defined according to the Academic Research Consortium definition
All-cause of death	1 year

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of