Actively Recruiting
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation Insights From TREX Registry
Led by San Luigi Gonzaga Hospital · Updated on 2024-07-08
382
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two advanced stenting techniques, T-stenting And Minimal Protrusion (TAP) and External Minicrush, for treating complex coronary bifurcation in patients with coronary artery disease, including ischemic heart disease and acute or chronic coronary syndromes. These techniques are used when patients require percutaneous coronary intervention (PCI) at coronary bifurcation points, but differences in procedural, clinical, and safety outcomes between these methods remain unclear. The study builds on prior findings about related stenting methods and aims to clarify which technique may reduce complications like stent thrombosis and restenosis. Participants will undergo PCI following current coronary revascularization guidelines, with operators choosing vascular access and antiplatelet strategies based on patient characteristics. The TAP technique involves stenting the main vessel, rewiring to the side branch, and performing balloon inflations to open the side branch, followed by side branch stent implantation and final balloon inflations. The External Minicrush method includes side branch stent deployment with protrusion into the main vessel, crushing the side branch stent with a balloon, main vessel stenting, rewiring, and further balloon inflations including proximal optimization. Throughout the study, researchers will monitor participants over five years, focusing on outcomes such as target lesion failure, stent thrombosis, intrastent restenosis, and target vessel myocardial infarction. Participants will receive standard PCI care with follow-up assessments to evaluate the long-term safety and efficacy of the two stenting strategies. The overall goal is to improve treatment approaches for complex coronary bifurcation by understanding differences between these two techniques.
CONDITIONS
Brief Title
Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients indicated 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)
You will not qualify if you...
- Patients who do not want or cannot sign informed consent
- Patients with severe peripheral vascular disease limiting vascular access
- Patients with life expectancy less than 1 year
- Patients planning major surgery requiring prolonged stopping of antiplatelet therapy
- Pregnant women
- Patients unable to take antiplatelet therapy for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo a percutaneous coronary intervention (PCI) using either the T-stenting And Minimal Protrusion or External Minicrush technique to treat complex coronary bifurcation.
1 visit (in-person)
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess safety and efficacy outcomes including target lesion failure, stent thrombosis, and in-stent restenosis.
Follow-up visits as scheduled over 5 years
Trial Site Locations
Total: 1 location
1
Rivoli Hospital
Rivoli, Turin, Italy, 10098
Actively Recruiting
Research Team
G
Giulio Piedimonte, MD
E
Enrico Cerrato, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here