Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

Conditions
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Coronary Artery Disease (Left Main)

Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Endpoint- Target Lesion Failure (TLF) | TLF defined as cardiac death, MI not attributable to a non target vessel, or clinically driven target lesion revascularization | 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 | 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Angiographic success without occurence of death, target lesion related MI or target lesion revascularization prior to hospital discharge visit | 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 | 30 days post procedure | 
| Cardiac Death Rate |  | 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 | 
| Clinically Driven Target Lesion Revascularization |  | 30 days, 12 months and 24 months post procedure | 
| Stroke Events Rate |  | 30 days, 12 and 24 months post procedure | 
| Stent Thrombosis Events Rate |  | 30-day, 12-month and 2 year post-procedure | 
| Index Procedure Duration |  | End of the index procedure | 
| Fluoroscopy Time, during Index Procedure |  | End of the index procedure | 
| Acute Stent Malappositon by IVUS (IVUS Substudy) | Assessed in a subset of patients | End of the index procedure | 
| Minimal Lumen Area by IVUS (IVUS substudy) | Assessed in a subset of patients | End of the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left main, stent, self-expandable, DES, Stentys