Coronary Self Expanding Stent Clinical Trial
— WINOfficial title:
World-wide Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
| Verified date | May 2017 |
| Source | Stentys |
| Contact | David Bouchez |
| Phone | +33 1 44 53 99 42 |
| david.bouchez[@]stentys.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 750 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Age =18 years; 2. Presence of de novo coronary artery stenosis of =50% in a coronary artery suitable for implantation of the XPOSITION S STENT; 3. Vessel reference vessel diameter > 2.5 mm and = 6.0 mm without excessive tortuosity or diffuse distal disease; 4. The target lesion is suitable for a drug-eluting self-expanding stent indication, as assessed by investigator; 5. The target lesion is 10mm or longer; 6. The patient has been fully informed of the study, written informed consent as approved by the applicable Ethics Committee. 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: 1. Ostial left main lesion; 2. Presence of severe calcifications 3. Vessel diameter is smaller than 3.0mm |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | OLVG | Amsterdam | |
| Switzerland | Kantonsspital | St. Gallen |
| Lead Sponsor | Collaborator |
|---|---|
| Stentys |
Netherlands, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | TVF at 1 Year | 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 | |
| Secondary | Acute success rates | Device Success: Attainment of < 20% final in-stent residual stenosis of the target lesion with the XPOSITION S; Lesion Success: Attainment of < 20% final in-stent residual stenosis of the target lesion using any percutaneous method; Procedure Success: TIMI grade 3 and no in-hospital MACE |
From Index procedure up to hospital discharge (48 hours post procedure) | |
| Secondary | Stent thrombosis | Stent thrombosis (definite/probable) - Academic Research Consortium (ARC) definition | 1-year and 2-year follow-up post procedure |