Coronary Artery Disease
Conditions
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.
Interventions
DEVICECrush technique
Treatment for bifurcation with the Crush technique
DEVICECulotte technique
Treatment for bifurcation with the culotte technique
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 1 year | The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel myocardial infarction | 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 | 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. |
| Cardiovascular death | 1 year | Death resulting from cardiovascular causes. |
| Target-vessel or non-target vessel myocardial infarction | 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 | 1 year | Stent thrombosis is defined according to the Academic Research Consortium definition |
| All-cause of death | 1 year | — |
Countries
South Korea
Contacts
Primary ContactByeong-Keuk Kim, MD, PhD
Outcome results
None listed