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
5 years, 11 months, 5 days
Research summary
TITLE: "Safety and Performance in de novo lesion of native coronary arteries with Magmaris - Registry: BIOSOLVE-IV".
This registry will investigate the performance and safety of the 'Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold' system, hereafter referred to as ‘Magmaris’.
Magmaris scaffolds are used to re-open narrowings in coronary arteries to improve the blood supply to the heart muscle. Magmaris is similar to a coronary stent. However, where a stent would leave a permanent metal structure in the coronary artery, Magmaris is designed to completely dissolve over a period of several months. This is what is meant by ‘resorbable’. This is a new technology with a number of potential benefits and is already an approved and market-released product in the UK.
The registry will enroll 2054 patients with symptomatic coronary artery disease. Each patient will be followed-up for 5 years. The specific patients to be enrolled in the registry are already suitable candidates for treatment with Magmaris and could be treated appropriately with Magmaris, even if they did not participate in the registry. This is an ‘observational’ registry, so patients’ medical treatment is not altered by their participation.
The registry will primarily measure how many patients have a significant recurrence of narrowing or blockage, within the section of coronary 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 and how many die, will be collected for analysis at the same intervals. All untoward medical occurrences will be recorded and monitored throughout the registry. A research nurse will telephone the patients at the specified intervals to collect the required information.
The registry will increase our understanding of the effectiveness of Magmaris.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0385
Date of REC Opinion
20 Dec 2018
REC opinion
Unfavourable Opinion