Comparing two stent techniques for treating coronary artery bifurcation lesions
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 512 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05488665 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with specific de novo bifurcation lesions suitable for drug-eluting stent implantation.
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.
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 performed: Previous studies have explored various stenting techniques for bifurcation lesions, but this specific comparison of crush versus culotte techniques is relatively novel.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.