Overview

This trial is active, not recruiting.

Conditions cardiovascular diseases, coronary artery disease, myocardial ischemia, coronary disease, coronary restenosis, heart diseases, coronary stenosis, arteriosclerosis, arterial occlusive diseases, vascular diseases
Sponsor Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Collaborator Abbott Vascular
Start date April 2012
End date March 2013
Trial size 180 participants
Trial identifier NCT01583608, BVS 12

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)
time frame: at 24 months

Secondary Outcomes

Measure
Acute procedural success
time frame: At the end of hospital stay (maximum of 7 days)
Acute device success
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)
time frame: At time of intervention, and at 6, 12, 24, 36 months
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
Ischemia driven target vessel revascularisation (TVR)
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)
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
Coronary artery bypass grafting (CABG)
time frame: at 6, 12, 24, 36 month

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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: Eligible: 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 - TIMI ≥1 - 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 Not eligible: 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 - Aorto-ostial location - 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) - Heavy calcification - Restenotic from previous intervention - Target vessel is containing thrombus

Additional Information

Official title ABSORB: Initial Clinical Experience With the Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) System in the Treatment of de Novo Native Coronary Artery Lesions - a Surveillance Registry
Principal investigator Detlef G Mathey, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd..