Status:
COMPLETED
Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.
Detailed Description
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensive...
Eligibility Criteria
Inclusion
- Coroflex® ISAR NEO is intended to be used for
- All common significant coronary lesions
- Target lesion length \>34mm need to be covered with at least 2 stents
- Patients eligible for this study must be at least 18 years of age.
- The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.
Exclusion
- Intolerance to sirolimus and/or probucol
- Allergy to components of the coating
- Pregnancy and lactation
- Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
- Cardiogenic shock
- Risk of an intraluminal thrombus
- Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
- Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
- Severe allergy to contrast media
- Lesions which are untreatable with PCI or other interventional techniques
- Patients with an ejection fraction of \< 30 %
- Vascular reference diameter \< 2.00 mm
- Treatment of the left stem (first section of the left coronary artery)
- Indication for a bypass surgery
- Contraindication for whichever accompanying medication is necessary
Key Trial Info
Start Date :
January 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
3520 Patients enrolled
Trial Details
Trial ID
NCT03809715
Start Date
January 17 2019
End Date
August 15 2025
Last Update
January 8 2026
Active Locations (1)
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1
Clinique St. Hilaire
Rouen, France, 76000