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About
The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients with complex de novo native coronary artery lesions in all-day clinical practice.
Full description
Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a result of everolimus release, neointimal growth is inhibited similar to DES. Finally the implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and angulation as well as response to nitroglycerine and endothelial function.
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Inclusion and exclusion criteria
The recommendation to implant BVS in an individual patient in whom rotational atherectomy of a complex target lesion has been conducted, is purely based on clinical grounds. These are determined by the instructions for use (IFU) of the BVS and by the clinical experience accumulated so far from clinical studies.These studies suggest that the BVS should be implanted under certain conditions, which are determined by the patient and the coronary lesion treated:
Eligible:
Regarding to patient
Regarding to lesion
Not eligible:
Regarding to patient
Regarding to lesion
Target lesion(s) meets none of the following criteria:
Target vessel is not containing thrombus
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Central trial contact
Detlef G Mathey, Prof. Dr.
Data sourced from clinicaltrials.gov
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