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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 512 participants in total. It began in 2022-11-10 with a primary completion date of 2027-09-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Byeong-Keuk Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Frequently Asked Questions
Who can join the NCT05488665 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05488665 currently recruiting?
Yes, NCT05488665 is actively recruiting participants. Contact the research team at KIMBK@yuhs.ac for enrollment information.
Where is the NCT05488665 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05488665 clinical trial?
NCT05488665 is sponsored by Yonsei University. The principal investigator is Byeong-Keuk Kim, MD, PhD at Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine. The trial plans to enroll 512 participants.