Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease
- Conditions
- Coronary Artery Disease (Left Main)
- Registration Number
- NCT02800837
- Lead Sponsor
- Stentys
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Subject ≥ 18 years old;
- Presence of coronary artery stenosis in the unprotected Left Main (LM) Coronary Artery which is indicated for PCI and Xposition S stent treatment
- Left Main Coronary Artery reference vessel diameter ranging from 2.5 mm to 6.0 mm;
- The subject is able to provide voluntary informed consent, willing to comply with all study requirements and sign the written informed consent.
Main
- Recent STEMI (<1 month) ;
- SYNTAX score ≥ 33 ;
- Highly calcified lesions or excessive tortuosity at target lesion site;
- Subject unable to comply with dual antiplatelet therapy as recommended per guidelines;
- Planned cardiac surgery or valve intervention within the next 12 months.
- Participation to other investigational drug or device studies that have not reached their primary endpoint.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Endpoint - Angiographic Success 12 months post-procedure Achievement of \<20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch
Clinical Endpoint- Target Lesion Failure (TLF) 12 months post-procedure TLF defined as cardiac death, MI not attributable to a non target vessel, or clinically driven target lesion revascularization
- Secondary Outcome Measures
Name Time Method Procedural Success 48 hours post procedure (hospital discharge) Angiographic success without occurence of death, target lesion related MI or target lesion revascularization prior to hospital discharge visit
Clinically Driven Target Lesion Revascularization 30 days, 12 months and 24 months post procedure MI rate (not attributable to a non target vessel) 30 days, 12 months and 24 months post procedure Stroke Events Rate 30 days, 12 and 24 months post procedure TLF 30 days post procedure TLF defined as cardiac death, Myocardial Infarction(MI) not attributable to a non target vessel, or clinically driven target lesion revascularization
Cardiac Death Rate 30 days, 12 months and 24 months post procedure Fluoroscopy Time, during Index Procedure End of the index procedure Minimal Lumen Area by IVUS (IVUS substudy) End of the index procedure Assessed in a subset of patients
Stent Thrombosis Events Rate 30-day, 12-month and 2 year post-procedure Index Procedure Duration End of the index procedure Acute Stent Malappositon by IVUS (IVUS Substudy) End of the index procedure Assessed in a subset of patients
Trial Locations
- Locations (4)
Ferraroto Hospital - Catania University
🇮🇹Catania, Italy
Clinica Mediterranea
🇮🇹Naples, Italy
Bristol Heart Institute
🇬🇧Bristol, United Kingdom
St Gallen Kantonsspital
🇨🇭St Gallen, Switzerland