Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03809715
- Lead Sponsor
- B. Braun Melsungen AG
- 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 extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3520
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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Lesion Revascularization (TLR) rate at 12 months 12 months
- Secondary Outcome Measures
Name Time Method Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events) 12 months Rate of bleeding complications accumulated up to 12 months 12 months To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.
Stent thrombosis rates accumulated up to 12 months 12 months Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events) 12 months MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
Technical/procedural success rate immediately after procedure
Trial Locations
- Locations (1)
Clinique St. Hilaire
🇫🇷Rouen, France