ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease (ASSURE)
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ClinicalTrials.gov Identifier: NCT01583608
Recruitment Status :
First Posted : April 24, 2012
Last Update Posted : December 9, 2016
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Information provided by (Responsible Party):
Detlef Mathey, Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
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.
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE) [ Time Frame: at 24 months ]
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death
Secondary Outcome Measures :
Acute procedural success [ Time Frame: At the end of hospital stay (maximum of 7 days) ]
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.
Acute device success [ Time Frame: At time of intervention ]
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.
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) [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ]
Target lesion denominates scaffolded segment and 5 mm beyond.
Major Adverse Cardiac Event (MACE) [ 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 ]
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death
Ischemia driven target vessel revascularisation (TVR) [ Time Frame: at 6, 12, 24, 36 months ]
TVR is ischemia driven.
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) [ Time Frame: Prior and post procedure and at angiographic follow-up if applicable ]
Angulation (°) [ Time Frame: Prior and post procedure and at angiographic follow-up if applicable ]
Clinical success [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ]
Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
Coronary artery bypass grafting (CABG) [ Time Frame: at 6, 12, 24, 36 month ]
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with cardiovascular disease
The recommendation to implant BVS in an individual patient 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:
Regarding to patient
Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic heart disease (chronic, NSTEMI and unstable angina) due to one or more de novo native coronary artery lesions
Patients with evidence of myocardial ischemia
Regarding to lesion
Reference vessel diameter ≥ 2.0 mm and ≤ 3.8 mm, visually estimated and by online QCA
Percent diameter stenosis ≥ 50% and < 100%, visually estimated and by online QCA
Previous interventions of target vessel lesions should have been done ≥ 6 months prior to index procedure and > 10 mm distal to the target lesion
Previous interventions of non-target vessel lesions should have been done ≥ 30 days prior to index procedure
In case of >1 target lesions, those should be from different epicardial vessels
Regarding to patient
Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated
Patient with a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated
Patient has a known diagnosis of acute myocardial infarction (STEMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
Patient is currently experiencing clinical symptoms consistent with STEMI
Patient has current unstable arrhythmias
Patient has a known left ventricular ejection fraction < 30%
Patient has received a heart transplant or any other organ transplant or is waiting for any organ transplant
Patient receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after procedure
Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease
Patient is receiving or scheduled to receive chronic anticoagulation therapy
Elective surgery is planned within the first 6 month after the procedure that will require discontinuing either aspirin or clopidogrel
Patient has a platelet count < 100 000 cells/mm3 or > 700 000 cells/mm3, a WBC of
< 3000 cells/mm3, or documented or suspected liver disease
Patient has known renal insufficiency
Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Patient has cerebrovascular accident or transient ischemic neurological attack within the past six month
Patient has had a significant GI or urinary bleed within the past six months
Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non.compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., les than one year)
Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal
Regarding to lesion
Left main location
Located within 2 mm of the origin of LAD or LCX
Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
Lesion involving a bifurcation with side branch vessel ≥ 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation
Total occlusion (TIMI flow 0), prior to wire passing
Excessive tortuosity proximal to or within the lesion (extreme angulation (≥ 90°) proximal to or within the lesion)