The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery lesions in all-day clinical practice.
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.
Study Type
OBSERVATIONAL
Enrollment
183
Medical Care Center Prof. Mathey, Prof. Schofer GmbH
Hamburg, Hamburg, Germany
Herzzentrum Brandenburg in Bernau
Bernau, Germany
Klinikum Coburg GmbH
Coburg, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsklinikum Ulm
Ulm, Germany
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death
Time frame: at 24 months
Acute procedural success
Achievement of final in-scaffold residual stenosis of \< 50% and TIMI flow 3 of the target site. Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet clinical procedure success criteria.
Time frame: At the end of hospital stay (maximum of 7 days)
Acute device success
Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system. Attainment of \< 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.
Time frame: At time of intervention
Scaffold thrombosis
Time frame: At time of intervention, and at 6, 12, 24, 36 months
Cardiac death
Time frame: At time of intervention, and at 6, 12,24, 36 months
Myocardial infarction
Time frame: At time of intervention, and at 6, 12, 24 36 months
Ischemia driven target lesion revascularisation (TLR)
Target lesion denominates scaffolded segment and 5 mm beyond.
Time frame: At time of intervention, and at 6, 12, 24, 36 months
Major Adverse Cardiac Event (MACE)
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death
Time frame: At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 36 months
Ischemia driven target vessel revascularisation (TVR)
TVR is ischemia driven.
Time frame: at 6, 12, 24, 36 months
Ischemia driven target vessel failure (TVF)
Time frame: at 6, 12, 24, 36 month
In-lesion % diameter stenosis
Time frame: Prior procedure
In-scaffold % diameter stenosis
Time frame: At time of intervention and at angiographic FU if applicable
Minimal lumen diameter (MLD)
Time frame: Prior and post procedure and at FU if applicable
In-scaffold late lumen loss (LLL)
Time frame: At angiographic follow-up if applicable
Proximal and distal late lumen loss (LLL)
Time frame: At angiographic follow-up if applicable
In-lesion late lumen loss
Time frame: At angiographic follow-up if applicable
Response to nitroglycerin
Time frame: Before scaffold implantation, during angiographic follow-up if applicable
In-lesion angiographic binary restenosis (≥ 50%)
Time frame: At angiographic follow-up if applicable
Curvature (cm-1)
treated region
Time frame: Prior and post procedure and at angiographic follow-up if applicable
Angulation (°)
Treated region
Time frame: Prior and post procedure and at angiographic follow-up if applicable
Clinical success
Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
Time frame: At time of intervention, and at 6, 12, 24, 36 months
Coronary artery bypass grafting (CABG)
Time frame: at 6, 12, 24, 36 month
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