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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.
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.
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| 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 |
| 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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Patients with coronary artery stenosis (unprotected left main coronary artery), indicated for Percutaneous Coronary Intervention (PCI) and Xposition S stent treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferraroto Hospital - Catania University | Not yet recruiting | Catania | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25639945 | Background | Briguori C, Visconti G, Donahue M, Focaccio A, Mitomo S, Kawamoto H, Nakamura S. The STENTYS(R) 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| Clinica Mediterranea | Not yet recruiting | Naples | Italy |
|
| St Gallen Kantonsspital | Recruiting | Sankt Gallen | Switzerland |
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| Bristol Heart Institute | Not yet recruiting | Bristol | United Kingdom |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |