RECRUITINGINTERVENTIONAL
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Crush technique
Treatment for bifurcation with the Crush technique
DEVICE
Culotte technique
Treatment for bifurcation with the culotte technique
Locations (1)
Yonsei University Health System, Severance Hospital
Seoul, South Korea