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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Crush technique; Device: Culotte technique

• Study Type: Interventional
• Enrollment (Estimated): 512
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Byeong-Keuk Kim, MD, PhD; Phone Number: 82-02-2228-8465; Email: KIMBK@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University Health System, Severance Hospital
    • Contact: Byeong-Keuk Kim, MD, PhD; Phone Number: 82-02-2228-8465; Email: KIMBK@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crush technique group; Two stenting with the Crush technique	Device: Crush technique; Treatment for bifurcation with the Crush technique
Active Comparator: Culotte technique group; Two stenting with the Culotte technique	Device: Culotte technique; Treatment for bifurcation with the culotte technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure	The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Death resulting from cardiovascular causes.	1 year
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
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
All-cause of death		1 year
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
Definite or probable stent thrombosis	Stent thrombosis is defined according to the Academic Research Consortium definition	1 year

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Byeong-Keuk Kim, MD, PhD, Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): September 27, 2027
• Study Completion (Estimated): September 27, 2028

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 1-2022-0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No