Coroflex ISAR NEO Drug Eluting Coronary Stent PMCF Study
Research type
Research Study
Full title
Post-market clinical follow-up (PMCF) investigation plan for evaluating the clinical safety and effectiveness of the Coroflex ISAR NEO stent for the treatment of coronary disease.
IRAS ID
363198
Contact name
Abhishek Kumar
Contact email
Sponsor organisation
Fundacion Epic
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 1 days
Research summary
The Post-Market Clinical Follow-up (PMCF) investigational study is a standardized way of collecting safety and effectiveness data on the Coroflex® ISAR NEO coronary stent used in patient intervention and/or in the treatment of their coronary disease in hospital.
The intended patients have one or more lesions on their coronary arteries causing them to narrow and they also are patients that have a high risk of bleeding. Their doctors have decided that it is necessary to treat the patient's disease by implanting a drug-eluting stent (DES), in their case at least one of the Coroflex® ISAR NEO coronary stent, which is a device approved for the treatment of narrowing coronary arteries and for use in routine clinical practice. The patients are receiving treatment in this way independent of the registry.
3,000 patients will be included in this partially retrospective, partially prospective multicenter study (Spain, Germany, France and United Kingdom), which aims to collect information on the safety and effectiveness of this stent, including details on the procedure and clinical results up to 24 months after the stent has been implanted as part of the post-marketing MDR requirements for CE marked devices. All of the patient collected medical data will be coded anonymously, ensuring that their confidentiality is protected in accordance with current legislation.
REC name
North of Scotland Research Ethics Committee 1
REC reference
26/NS/0039
Date of REC Opinion
1 May 2026
REC opinion
Favourable Opinion