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

Coronary Artery Disease Clinical Trial

— COMPLETE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488665
• Other study ID #: 1-2022-0033
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Yonsei University
• Contact: Byeong-Keuk Kim, MD, PhD
• Phone: 82-02-2228-8465
• Email: KIMBK[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 512
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion criteria:

1. Age =19 years

2. De novo coronary lesions eligible for drug-eluting stent implantation

3. Medina 1,1,1 or 1,0,1 or 0,1,1 de novo bifurcation lesions (LM or non-LM) and those of main vessel or side branch can be covered by 2 stents

4. Reference vessel diameter of side branch =2.5 mm by visual estimation

Exclusion criteria

1. Current or potential pregnancy

2. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

3. Subjects with ST elevation myocardial infarction <24 h from the onset of chest pain

4. Cardiogenic Shock

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Crush technique
Treatment for bifurcation with the Crush technique
• Culotte technique
Treatment for bifurcation with the culotte technique

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization	1 year
Secondary	Cardiovascular death	Death resulting from cardiovascular causes.	1 year
Secondary	Target vessel myocardial infarction	The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.	1 year
Secondary	Clinically driven target-lesion revascularization	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.	1 year
Secondary	All-cause of death		1 year
Secondary	Target-vessel or non-target vessel myocardial infarction	The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.	1 year
Secondary	Definite or probable stent thrombosis	Stent thrombosis is defined according to the Academic Research Consortium definition	1 year