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.
Study Type
OBSERVATIONAL
Enrollment
200
Ferraroto Hospital - Catania University
Catania, Italy
NOT_YET_RECRUITINGClinica Mediterranea
Naples, Italy
NOT_YET_RECRUITINGSt Gallen Kantonsspital
Sankt Gallen, Switzerland
RECRUITINGClinical Endpoint- Target Lesion Failure (TLF)
TLF defined as cardiac death, MI not attributable to a non target vessel, or clinically driven target lesion revascularization
Time frame: 12 months post-procedure
Efficacy Endpoint - Angiographic Success
Achievement of \<20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch
Time frame: 12 months post-procedure
Procedural Success
Angiographic success without occurence of death, target lesion related MI or target lesion revascularization prior to hospital discharge visit
Time frame: 48 hours post procedure (hospital discharge)
TLF
TLF defined as cardiac death, Myocardial Infarction(MI) not attributable to a non target vessel, or clinically driven target lesion revascularization
Time frame: 30 days post procedure
Cardiac Death Rate
Time frame: 30 days, 12 months and 24 months post procedure
MI rate (not attributable to a non target vessel)
Time frame: 30 days, 12 months and 24 months post procedure
Clinically Driven Target Lesion Revascularization
Time frame: 30 days, 12 months and 24 months post procedure
Stroke Events Rate
Time frame: 30 days, 12 and 24 months post procedure
Stent Thrombosis Events Rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bristol Heart Institute
Bristol, United Kingdom
Time frame: 30-day, 12-month and 2 year post-procedure
Index Procedure Duration
Time frame: End of the index procedure
Fluoroscopy Time, during Index Procedure
Time frame: End of the index procedure
Acute Stent Malappositon by IVUS (IVUS Substudy)
Assessed in a subset of patients
Time frame: End of the index procedure
Minimal Lumen Area by IVUS (IVUS substudy)
Assessed in a subset of patients
Time frame: End of the index procedure