ABSORB UK Registry V1
Research type
Research Study
Full title
ABSORB UK Registry - A post-market registry of patients with de novo lesions in previously untreated vessels treated with Absorb BVS
IRAS ID
141728
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Abbott Vascular
Clinicaltrials.gov Identifier
Research summary
ABSORB UK Registry is a post market registry. The registry aim is to continue collecting information about the safety and clinical effectiveness of the ABSORB BVS scaffold, now it is in general use. The scaffold (stent) is made by Abbott Cardiovascular Systems Inc. It is CE marked and approved for use in the UK and Europe. Abbott is sponsoring the registry.
Patients who have a narrowing in their coronary (heart) arteries (blood vessels) can be treated with a procedure called percutaneous coronary intervention (PCI). A stent (small mesh tube) is put in the damaged or diseased artery to keep the narrow part of the artery open and allow more blood to flow through. The stents that are commonly used stay in the artery and gradually become incorporated into the artery wall. A newer type of stent, the ABSORB BVS scaffold, is made from a material that is slowly absorbed into the body over a period of 2-3 years.
15 – 30 hospitals in the UK will enrol 1000 patients (men and women over 18 who need treatment with an ABSORB BVS scaffold). Patients will receive standard care throughout. Information about each patient (medical condition and medications) will be collected around the time of the PCI and at 1 and 3 years after the PCI procedure.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0476
Date of REC Opinion
3 Jan 2014
REC opinion
Further Information Favourable Opinion