The COMPLETE Treatment of Bifurcation With Two-stent Tech... | NCT05488665

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

NCT05488665

Sponsor

Yonsei University

Status

Recruiting

Last Update Posted

Oct 23, 2024Actual

Enrollment

512Estimated

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

Crush technique
Culotte technique

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2022Actual

Primary Completion Date

Sep 27, 2027Estimated

Completion Date

Sep 27, 2028Estimated

First Submitted Date

Aug 3, 2022

First Submission Date that Met QC Criteria

Aug 3, 2022

First Posted Date

Aug 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

512Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Crush technique group	Experimental	Two stenting with the Crush technique	Device: Crush technique
Culotte technique group	Active Comparator	Two stenting with the Culotte technique	Device: Culotte technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crush technique	Device	Treatment for bifurcation with the Crush technique	Crush technique group

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age ≥19 years
De novo coronary lesions eligible for drug-eluting stent implantation
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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Byeong-Keuk Kim, MD, PhD	Contact	82-02-2228-8465		KIMBK@yuhs.ac

Overall Officials

Name	Affiliation	Role
Byeong-Keuk Kim, MD, PhD	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System, Severance Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided