Coronary Artery Disease (Left Main) Clinical Trial
— TRUNCOfficial title:
Multicenter Prospective Clinical Study of the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | June 2019 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ferraroto Hospital - Catania University | Catania | |
| Italy | Clinica Mediterranea | Naples | |
| Switzerland | St Gallen Kantonsspital | St Gallen | |
| United Kingdom | Bristol Heart Institute | Bristol |
| Lead Sponsor | Collaborator |
|---|---|
| Stentys |
Italy, Switzerland, United Kingdom,
Briguori C, Visconti G, Donahue M, Focaccio A, Mitomo S, Kawamoto H, Nakamura S. The STENTYS® paclitaxel-eluting stent in the treatment of unprotected distal left main. Catheter Cardiovasc Interv. 2015 Sep;86(3):E131-9. doi: 10.1002/ccd.25874. Epub 2015 Feb 25. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | No |
| Secondary | 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) | No |
| Secondary | 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 | Yes |
| Secondary | Cardiac Death Rate | 30 days, 12 months and 24 months post procedure | Yes | |
| Secondary | MI rate (not attributable to a non target vessel) | 30 days, 12 months and 24 months post procedure | Yes | |
| Secondary | Clinically Driven Target Lesion Revascularization | 30 days, 12 months and 24 months post procedure | Yes | |
| Secondary | Stroke Events Rate | 30 days, 12 and 24 months post procedure | Yes | |
| Secondary | Stent Thrombosis Events Rate | 30-day, 12-month and 2 year post-procedure | Yes | |
| Secondary | Index Procedure Duration | End of the index procedure | No | |
| Secondary | Fluoroscopy Time, during Index Procedure | End of the index procedure | No | |
| Secondary | Acute Stent Malappositon by IVUS (IVUS Substudy) | Assessed in a subset of patients | End of the index procedure | No |
| Secondary | Minimal Lumen Area by IVUS (IVUS substudy) | Assessed in a subset of patients | End of the index procedure | No |