The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
COMPLETE
1 other identifier
interventional
512
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Nov 2022
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2022
CompletedFirst Posted
Study publicly available on registry
August 4, 2022
CompletedStudy Start
First participant enrolled
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 27, 2028
October 23, 2024
October 1, 2024
4.9 years
August 3, 2022
October 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Target lesion failure
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization
1 year
Secondary Outcomes (6)
Cardiovascular death
1 year
Target vessel myocardial infarction
1 year
Clinically driven target-lesion revascularization
1 year
All-cause of death
1 year
Target-vessel or non-target vessel myocardial infarction
1 year
- +1 more secondary outcomes
Study Arms (2)
Crush technique group
EXPERIMENTALTwo stenting with the Crush technique
Culotte technique group
ACTIVE COMPARATORTwo stenting with the Culotte technique
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Health System, Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byeong-Keuk Kim, MD, PhD
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2022
First Posted
August 4, 2022
Study Start
November 10, 2022
Primary Completion (Estimated)
September 27, 2027
Study Completion (Estimated)
September 27, 2028
Last Updated
October 23, 2024
Record last verified: 2024-10