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

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Crush technique
Culotte technique
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥19 years
  2. De novo coronary lesions eligible for drug-eluting stent implantation
  3. Medina 1,1,1 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

Sites / Locations

  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crush technique group

Culotte technique group

Arm Description

Two stenting with the Crush technique

Two stenting with the Culotte technique

Outcomes

Primary Outcome Measures

Target lesion failure
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization

Secondary Outcome Measures

Cardiovascular death
Death resulting from cardiovascular causes.
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.
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.
All-cause of death
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.
Definite or probable stent thrombosis
Stent thrombosis is defined according to the Academic Research Consortium definition

Full Information

First Posted
August 3, 2022
Last Updated
August 3, 2022
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05488665
Brief Title
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
Acronym
COMPLETE
Official Title
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crush technique group
Arm Type
Experimental
Arm Description
Two stenting with the Crush technique
Arm Title
Culotte technique group
Arm Type
Active Comparator
Arm Description
Two stenting with the Culotte technique
Intervention Type
Device
Intervention Name(s)
Crush technique
Intervention Description
Treatment for bifurcation with the Crush technique
Intervention Type
Device
Intervention Name(s)
Culotte technique
Intervention Description
Treatment for bifurcation with the culotte technique
Primary Outcome Measure Information:
Title
Target lesion failure
Description
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiovascular death
Description
Death resulting from cardiovascular causes.
Time Frame
1 year
Title
Target vessel myocardial infarction
Description
The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.
Time Frame
1 year
Title
Clinically driven target-lesion revascularization
Description
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.
Time Frame
1 year
Title
All-cause of death
Time Frame
1 year
Title
Target-vessel or non-target vessel myocardial infarction
Description
The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document.
Time Frame
1 year
Title
Definite or probable stent thrombosis
Description
Stent thrombosis is defined according to the Academic Research Consortium definition
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥19 years De novo coronary lesions eligible for drug-eluting stent implantation Medina 1,1,1 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 Reference vessel diameter of side branch ≥2.5 mm by visual estimation Exclusion Criteria: Current or potential pregnancy Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator Subjects with ST elevation myocardial infarction <24 h from the onset of chest pain Cardiogenic Shock
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byeong-Keuk Kim, MD, PhD
Phone
82-02-2228-8465
Email
KIMBK@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim, MD, PhD
Organizational Affiliation
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim, MD, PhD
Phone
82-02-2228-8465
Email
KIMBK@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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