Evaluating bifurcation coronary interventions using two techniques
Official title: Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).
Run by Miedziowe Centrum Zdrowia SA · NCT06284057 · Data updated 2026-11-12
This study looks at how well two different stenting techniques work for patients with heart artery blockages to see which one is safer and more effective.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Miedziowe Centrum Zdrowia SA Academic / other |
| Locations | 2 sites (Legnica, Lower Silesian Voivodeship and 1 other locations) |
| Status | Recruiting |
| Started | April 1, 2013 |
| Main results expected | April 1, 2028 |
| Study ends | April 1, 2028 |
| Registry record updated | March 6, 2024 |
| Trial ID | NCT06284057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with significant coronary bifurcation lesions requiring two stents using the Culotte or DK-Culotte techniques.
✕Probably not a fit
Patients who have previously undergone PCI with coronary stents for the same bifurcation lesion will 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 observational study analyzes outcomes from patients who underwent percutaneous coronary intervention (PCI) for bifurcation lesions using either the Culotte technique or the Double Kiss Culotte technique. The research is based on a retrospective review of data collected from two high-volume cardiac departments in Lower Silesia, Poland, between April 2012 and January 2024. The study aims to assess the safety and efficacy of these two stenting techniques in treating acute coronary syndrome. Decisions regarding the PCI procedures were made by a Heart Team based on clinical indications and angiographic features, ensuring informed consent was obtained from all participants.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with bifurcation lesions in coronary arteries.
How similar studies have gone: Previous studies have shown varying success with bifurcation PCI techniques, but this specific comparison of Culotte and DK-Culotte techniques is less commonly explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique. Exclusion Criteria: * Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.
Where it's running
-
Department of Cardiology, Provincial Specialized Hospital in Legnica,
Legnica, Lower Silesian Voivodeship, Poland Recruiting -
Department of Cardiology, The Copper Health Centre (MCZ)
Lubin, Lower Silesian Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Adrian Włodarczak, Assoc. Prof. — Miedziowe Centrum Zdrowia SA
- Study coordinator: Mateusz Barycki, MD
- Email: mateusz.barycki@gmail.com
- Phone: +48767211446
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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.