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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Culotte technique; Device: Crush technique

• 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

Arm && Interventions

Group	Intervention	Description
Culotte technique group	Culotte technique	Two stenting with the Culotte technique
Crush technique group	Crush technique	Two stenting with the Crush technique

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
All-cause of death	1 year
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

Trial Locations

Locations (1)

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