Comparing two techniques for treating complex coronary bifurcation
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry
This study is testing which of two techniques for treating complex heart artery blockages works better and is safer for adults needing heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 382 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | San Luigi Gonzaga Hospital Academic / other |
| Locations | 1 site (Rivoli, Turin) |
| Trial ID | NCT06484647 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the T-stenting And Minimal Protrusion (TAP) technique with the External Minicrush technique for treating complex coronary bifurcation lesions. It will assess procedural, clinical, and safety outcomes to determine which method is more effective. The study will include patients over 18 years old who require percutaneous coronary intervention (PCI) for conditions like chronic coronary syndrome and acute coronary syndromes. The research is significant as it addresses the lack of comparative data between these two techniques, which are commonly used in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are patients over 18 years old with an indication for PCI and at least one true coronary bifurcation.
Not a fit: Patients with severe peripheral vascular disease, those who cannot take antiplatelet therapy, or have a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved treatment outcomes for patients with complex coronary bifurcation.
How similar studies have performed: While similar techniques have been tested, this specific comparison between TAP and External Minicrush has not been previously studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 years of age * Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina) * Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1 Exclusion Criteria: * Patients who do not want or cannot sign the informed consent for the procedure. * Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe. * Patients with a life expectancy of \<1 year. * Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy. * Pregnant women. * Patients who cannot take antiplatelet therapy for any reason.
Where this trial is running
Rivoli, Turin
- Rivoli Hospital — Rivoli, Turin, Italy (Recruiting)
Study contacts
- Study coordinator: Giulio Piedimonte, MD
- Email: giulio.piedimonte@gmail.com
- Phone: +393201764900
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.