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WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice.
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S stent used in routine clinical practice. Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for elective percutaneous coronary interventions suitable for a self-expanding stent, can be included in the registry.
This registry will allow collecting data, and provide substantial information in a real world setting on patients with indications like lesions in vessels with diameter variance, large vessels, left main coronary artery, bifurcations, ectatic vessels, ...
WIN will enroll 750 patients from approximately 30 sites.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI | Device | PCI |
| Measure | Description | Time Frame |
|---|---|---|
| TLF at 1 Year follow-up | Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion Revascularization (TLR) | 1 year follow-up post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| TLF at 2 Year | Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion | 2 year follow-up post-procedure |
| TVF at 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
Known pregnancy or breastfeeding; 2. Known contraindication or hypersensitivity to any stent components, any PCI-related material or drug.
3. Concurrent medical condition with a life expectancy < 12 months; 4. Currently participating in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with this study endpoints; 5. Subjects undergoing cardiopulmonary resuscitation or in cardiogenic shock 6. Treatment of in-stent restenosis at target lesion; 7. Use of bioabsorbable/bioresorbable stents 8. Target lesion in left main coronary artery is excluded only if any of the following conditions is met:
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Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for Percutaneous Coronary Interventions suitable for a self-expanding drug eluting stent. Patient must be over legal age, and sign an authorization form for collection, transfer and processing of personal data.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Bouchez | Contact | +33 1 44 53 99 42 | david.bouchez@stentys.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG | Not yet recruiting | Amsterdam | Netherlands |
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Target Vessel Failure (TVF) defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically indicated Target Vessel Revascularization (TVR),
| 1 year follow-up post-procedure |
| Acute success rates |
| From Index procedure up to hospital discharge (48 hours post procedure) |
| Stent thrombosis | Stent thrombosis (definite/probable) - Academic Research Consortium (ARC) definition | 1-year and 2-year follow-up post procedure |
| Kantonsspital | Recruiting | Sankt Gallen | Switzerland |
|