Coronary Artery Disease (Left Main)
Conditions
Keywords
left main, stent, self-expandable, DES, 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.
Interventions
None listed
Sponsors
Stentys
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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) | End of the index procedure | Assessed in a subset of patients |
| 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 | — |
| 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 |
Countries
Italy, Switzerland, United Kingdom
Outcome results
None listed