Comparing two stent techniques for treating coronary artery bifurcation lesions
Official title: The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
Run by Yonsei University · NCT05488665 · Data updated 2026-11-12
This study is testing which of two stenting techniques works better for people with certain types of heart artery blockages to see which one helps them more after a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 512 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | November 10, 2022 |
| Main results expected | September 27, 2027 |
| Study ends | September 27, 2028 |
| Registry record updated | October 23, 2024 |
| Trial ID | NCT05488665 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19 and older with specific de novo bifurcation lesions suitable for drug-eluting stent implantation.
✕Probably not a fit
Patients who are pregnant, unable to commit to follow-up, or experiencing acute myocardial infarction or cardiogenic shock may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to compare the effectiveness of two stenting techniques, the crush technique and the culotte technique, for treating bifurcation lesions in patients with coronary artery disease. Using contemporary second-generation drug-eluting stents, the study will evaluate which technique leads to better outcomes in terms of target-lesion failure after one year. Eligible participants will be those with specific types of bifurcation lesions that can be treated with two stents. The study is randomized to ensure unbiased results.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective stenting technique for patients with bifurcation lesions, potentially improving their long-term outcomes.
How similar studies have gone: Previous studies have explored various stenting techniques for bifurcation lesions, but this specific comparison of crush versus culotte techniques is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Yonsei University Health System, Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Byeong-Keuk Kim, MD, PhD — Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
- Study coordinator: Byeong-Keuk Kim, MD, PhD
- Email: KIMBK@yuhs.ac
- Phone: 82-02-2228-8465
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.