BIOSOLVE-IV
Research type
Research Study
Full title
BIOTRONIKS - Safety and Performance in de Novo Lesion of Native Coronary Arteries with Magmaris- Registry: BIOSOLVE-IV
IRAS ID
242027
Contact name
Banu Eyueboglu Seitz
Contact email
Sponsor organisation
Biotronik AG
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 4 months, 30 days
Research summary
This registry investigates the performance and safety of the 'Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold', hereafter referred to as ‘Magmaris’.
Magmaris is used to re-open narrowings in coronary arteries to improve the blood supply to the heart muscle. Magmaris is similar to a conventional stent. However, a stent would leave a permanent metal structure in the artery, whereas Magmaris is designed to completely dissolve over time. This is what is meant by ‘resorbable’. This is a relatively new technology with potential benefits. It is already an approved and market-released product in the UK.
The registry will enroll 2054 patients with coronary artery disease. Each patient will be followed-up for 5 years. The patients to be enrolled in the registry in the UK will already have been treated with Magmaris, regardless of their participation in the registry. This is an ‘observational’ registry, so participants’ medical treatment is no different from that of patients receiving Magmaris outside of the registry.
The registry will primarily measure how many patients have a recurrent narrowing or blockage, within the section of artery where the Magmaris was implanted. This will be checked at 6, 12, 24, 36, 48 and 60 months after the procedure. Additional data, such as how many patients go on to have related heart attacks or die, will be collected for analysis at the same intervals. All untoward medical occurrences will be recorded, throughout the registry. A research nurse will review the medical records and telephone the patients at specified intervals to collect the required information.
The study will increase our understanding of the effectiveness of Magmaris.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0076
Date of REC Opinion
24 Apr 2019
REC opinion
Further Information Favourable Opinion