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.
Study Type
OBSERVATIONAL
Enrollment
3,000
The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.
Clinique Axium
Aix-en-Provence, France
RECRUITINGCHU CAEN
Caen, France
rate of target lesion failure
• 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
Time frame: 12 months post-procedure
Device success rate
• 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
Time frame: 12 months post-procedure
Procedural success rate
* 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
Time frame: 7 days post-procedure
Assess reperfusion
Target Lesion Revascularization at 12 months
Time frame: 12 months post-procedure
• Evaluate the antiplatelet treatment
antiplatelet consumption during 1 year after the procedure
Time frame: 12 months post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital A. Schweitzer - GHCA
Colmar, France
RECRUITINGClinique Louis Pasteur
Essey-lès-Nancy, France
RECRUITINGCH Haguenau
Haguenau, France
RECRUITINGCHU La Timone
Marseille, France
RECRUITINGHopital Nord
Marseille, France
NOT_YET_RECRUITINGHP Jacques Cartier
Massy, France
RECRUITINGClinique Pont de Chaume
Montauban, France
NOT_YET_RECRUITINGHôpital Privé du Confluent
Nantes, France
RECRUITING...and 9 more locations