Evaluating bifurcation coronary interventions using two techniques
Double Kissing (DK) vs Culotte Culotte. Lower Silesia Culotte Bifurcation Registry (LSCBR).
Regional Cardiology Center, The Copper Health Centre (MCZ), · NCT06284057
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regional Cardiology Center, The Copper Health Centre (MCZ), (other) |
| Locations | 2 sites (Legnica, Lower Silesian Voivodeship and 1 other locations) |
| Trial ID | NCT06284057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with significant coronary bifurcation lesions requiring two stents using the Culotte or DK-Culotte techniques.
Not a fit: Patients who have previously undergone PCI with coronary stents for the same bifurcation lesion will not benefit from this study.
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 performed: Previous studies have shown varying success with bifurcation PCI techniques, but this specific comparison of Culotte and DK-Culotte techniques is less commonly explored.
Eligibility criteria
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 this trial is running
Legnica, Lower Silesian Voivodeship and 1 other locations
- 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. — Regional Cardiology Center, The Copper Health Centre (MCZ),
- Study coordinator: Mateusz Barycki, MD
- Email: mateusz.barycki@gmail.com
- Phone: +48767211446
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.
Conditions: Safety Issues, Efficacy, Self, Percutaneous coronary intervention, Bifurcation lesion, Culotte Technique, Double Kiss Culotte Technique, Acute Coronary Syndrome, Two-Stent Technique