Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease.
In the treatment of unprotected left main coronary artery (ULMCA) disease, previous mono-center studies have shown promising results with the previous generation of the self-expandable STENTYS stent (paclitaxel eluting stent, delivered via withdrawal of a sheath).
The TRUNC study aims at assessing at large scale the Xposition S in the treatment of ULMCA disease. The Xposition S is a sirolimus eluting stent, mounted on a balloon delivery system. The study aims at collecting clinical practice routine data from 200 patients.
ClinicalTrials.gov ID: NCT02800837
Sponsor
STENTYS
Primary endpoints
- Clinical Endpoint: Target Lesion Failure at 12 months post-procedure
- Efficacy Endpoint: Angiographic success at 12 months post-procedure: Achievement of <20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch.
CERC Services
- Project management
- EDC and data management
- Monitoring activities
- Clinical Events Committee (CEC) activities
- Core Laboratory
- Safety reporting
- Statistical Analysis and Clinical report
Countries
France, Germany, Italy, Poland, Switzerland and The Netherlands managed by CERC.
Number of investigational sites
18 centers managed by CERC.
Number of patients
200
