NCT05488665 The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
| NCT ID | NCT05488665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 512 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2027-09-27 |
Trial Parameters
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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.
Eligibility Criteria
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