COMPARE ABSORB
Research type
Research Study
Full title
ABSORB bioresorbable scaffold vs. Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis
IRAS ID
186410
Contact name
Nick West
Contact email
Sponsor organisation
CERIC
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 9 days
Research summary
This is a multi-centre, single-blind, prospective randomized investigator-driven trial that will include 2100 patients in 10 countries. Included patients will present a high-risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent percutaneous coronary intervention. Once included in the study, patient will receive either Absorb scaffold or Xience stent and will be followed for 5 years. The results of this study will help to assess the non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year and the superiority of the BRS to the EES in TLF between 1 and 5 years.
This study will be composed of 3 ancillaries studies. One to determine the influence of BVS implantation on the short- (3- months) and long-term (2-years) endothelium-dependent vasomotion as measured by myocardial blood flow response to PET scintigraphy (Ancillary study of non-invasive imaging, conducted only in Switzerland). The second one to assess the performance of Absorb BVS family scaffold compared to Xience everolimus eluting stents family in diabetic patients with complex coronary artery disease (Ancillary diabetic substudy). The third one to evaluate the efficacy, performance and cost effectiveness of a web based, connected self-evaluation of angina using a companion dedicated tablet (SMART FUP®) during the first year of follow-up in the COMPARE ABSORB (smart follow-up substudy). An annex study will also be conducted on a specific population (patient with in stent restenosis) who will be excluded from the main study to evaluate the safety, efficacy and performance of Absorb scaffold in the treatment of subjects with ischemic heart disease caused by in-DES restenotic coronary artery lesion (Annex study of in-stent restenosis).REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0368
Date of REC Opinion
8 Dec 2015
REC opinion
Further Information Favourable Opinion