Artery Coronary Stenosis
Conditions
Brief summary
The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
Interventions
DEVICEPercutaneous Coronary Intervention
The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.
Sponsors
EVAMED
Translumina GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * Ability to provide signed informed consent form. * Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age) * Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis. * Patient having social security number. * Patient treated only with Vivo ISAR stent in case of single or multiple vessel stenting
Exclusion criteria
* Concurrent participation in another clinical trial. * Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR. * Planned elective surgery in next 6 months * Cardiogenic shock/ hemodynamically unstable patients * Concurrent medical condition with a life expectancy of less than 12 months * History of cerebrovascular accident in the last 6 months. * Vulnerable patient under guardianship or curatorship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of target lesion failure | 12 months post-procedure | • The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of: * Cardiac death * Myocardial infarction related to the target vessel * Clinically documented target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success rate | 12 months post-procedure | • Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis \<30% of the segment of the culprit lesion covered by the stent at 1 year |
| Procedural success rate | 7 days post-procedure | * Procedural success rate defined as device success without major ischemia-related adverse cardiac events during hospitalization and up to a maximum of 7 days post-procedure : * Cardiac death * Any MI * Target-vessel MI |
| Assess reperfusion | 12 months post-procedure | Target Lesion Revascularization at 12 months |
| • Evaluate the antiplatelet treatment | 12 months post-procedure | antiplatelet consumption during 1 year after the procedure |
Countries
France
Contacts
Primary ContactBéatrice GODEFROY
Outcome results
None listed