ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease

Completed

• Conditions: Arterial Occlusive Diseases; Coronary Restenosis; Cardiovascular Diseases; Heart Diseases; Coronary Stenosis; Myocardial Ischemia; Coronary Disease; Arteriosclerosis; Coronary Artery Disease; Vascular Diseases

• Registration Number: NCT01583608
• Lead Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Primary Completion: 2013-03
• Study Completion: 2016-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)	at 24 months	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death

Secondary Outcome Measures

Name	Time	Method
Scaffold thrombosis	At time of intervention, and at 6, 12, 24, 36 months
In-scaffold % diameter stenosis	At time of intervention and at angiographic FU if applicable
Minimal lumen diameter (MLD)	Prior and post procedure and at FU if applicable
Proximal and distal late lumen loss (LLL)	At angiographic follow-up if applicable
In-lesion late lumen loss	At angiographic follow-up if applicable
Cardiac death	At time of intervention, and at 6, 12,24, 36 months
In-scaffold late lumen loss (LLL)	At angiographic follow-up if applicable
Myocardial infarction	At time of intervention, and at 6, 12, 24 36 months
Ischemia driven target lesion revascularisation (TLR)	At time of intervention, and at 6, 12, 24, 36 months	Target lesion denominates scaffolded segment and 5 mm beyond.
Response to nitroglycerin	Before scaffold implantation, during angiographic follow-up if applicable
Curvature (cm-1)	Prior and post procedure and at angiographic follow-up if applicable	treated region
Angulation (°)	Prior and post procedure and at angiographic follow-up if applicable	Treated region
Clinical success	At time of intervention, and at 6, 12, 24, 36 months	Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
Acute procedural success	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	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.
In-lesion angiographic binary restenosis (≥ 50%)	At angiographic follow-up if applicable
Major Adverse Cardiac Event (MACE)	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)	at 6, 12, 24, 36 months	TVR is ischemia driven.
Ischemia driven target vessel failure (TVF)	at 6, 12, 24, 36 month
In-lesion % diameter stenosis	Prior procedure
Coronary artery bypass grafting (CABG)	at 6, 12, 24, 36 month

Trial Locations

Locations (6)

Klinikum Coburg GmbH; 🇩🇪 Coburg, Germany

Medical Care Center Prof. Mathey, Prof. Schofer GmbH; 🇩🇪 Hamburg, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Herzzentrum Brandenburg in Bernau; 🇩🇪 Bernau, Germany

Elisabeth-Krankenhaus Essen GmbH; 🇩🇪 Essen, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany