Yonsei University Health System, Severance Hospital
Seoul, South Korea
Location status: Recruiting
Recruiting
NCT Number: NCT05488665
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
19 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Crush technique
DeviceTreatment for bifurcation with the Crush technique
Culotte technique
DeviceTreatment for bifurcation with the culotte technique
Primary outcomes
-
Target lesion failure
Time frame: 1 year
The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization
Secondary outcomes
-
Cardiovascular death
Time frame: 1 year
Death resulting from cardiovascular causes.
-
Target vessel myocardial infarction
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
-
Target-vessel or non-target vessel myocardial infarction
Time frame: 1 year
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
Time frame: 1 year
Stent thrombosis is defined according to the Academic Research Consortium definition
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Yonsei University
Other
Registry information
Acronym: COMPLETE
Important dates
- Study start
- 2022
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Aug 4, 2022
- Registry last updated
- Oct 23, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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