STEMI DCB Trial, Protocol v 1.8 23.07.2025
Research type
Research Study
Full title
Drug Coated Balloon (Sequent Please Neo) vs Drug Eluting Stent treatment for acute ST-elevation myocardial infarction: a randomised trial
IRAS ID
356772
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
University Hospitals Sussex NHS Foundation Trust
Duration of Study in the UK
9 years, 0 months, 1 days
Research summary
The rapid treatment of patients with an acute heart attack ("STEMI - ST-elevation Myocardial Infarction") is well established in terms of its significant benefits. This is done using coronary angiography where a catheter is inserted (usually) through the wrist with local anaesthetic. The catheter is passed up to the heart and a balloon inflated at the point of the blockage to reopen it.
Once the artery is opened two potential options are available for trying to keep that artery open in the long-term. This involves either implanting a drug-eluting stent (DES) or inflating a drug-coated balloon (DCB) at the point of this blockage. Whilst DES have been used for many years it is now recognised that a significant number (2-4% per year) re-narrow over time and the physical presence of the stent is likely to contribute to this process. Therefore, many operators now use a DCB which coats the vessel with an anti-proliferative drug to prevent further narrowing but avoids the need for stent implantation. A direct comparison of these two approaches has not been performed.
DCB STEMI is a randomised non-inferiority trial to examine the safety and efficacy of DCB versus DES in patients admitted to hospital with a STEMI. The study will use CE marked DCB and DES devices. All devices used in this clinical investigation will be utilised in compliance with their approved Instructions for Use and in accordance with standard clinical practice.
The clinical investigation will recruit 700 patients from multiple sites within the UK. Eligible patients will be randomised 1:1 to receive either DES or DCB for treatment of STEMI. Follow-up examinations will be conducted in accordance with the usual practices of participating hospitals, with the addition of study specific follow-up at 1 month, 1 year, 3 years, 5 years and 8 years via telephone.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
25/LO/0630
Date of REC Opinion
24 Sep 2025
REC opinion
Further Information Favourable Opinion