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LOVE-DEB

Full Title: Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & efficacy of SELUTION SLR™ drug eluting balloon

Short Title: Love-DEB

Sponsor: Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Funder: M.A. Med Alliance SA

Chief Investigator: Dr Abhishek Kumar, Consultant Cardiologist, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust

Co-Investigators: Prof Amrita Ahluwalia, Professor of Vascular Pharmacology, Dean for Research, Queen Mary University of London & Director of Barts CVCTU; Professor Azfar Zaman, Consultant Interventional Cardiologist, Freeman Hospital, Newcastle upon Tyne

Contact: love-deb-cvctu@qmul.ac.uk

Registration: https://clinicaltrials.gov/study/NCT05915468

Study Design: Prospective, multicentre registry study

Objectives:

  • To evaluate the safety and efficacy of the SELUTION SLR™ sirolimus drug-eluting balloon in treating de novo native coronary artery disease in vessels ≥ 2.75 mm in diameter
  • To determine the proportion of participants requiring target lesion revascularisation within 1 year of the index PCI procedure

Number of Participants: 300

Devices Used: SELUTION SLR™ sirolimus drug-eluting balloon

Study Duration: 24 months

Locations: William Harvey Clinical Research Centre; Barts Health NHS Trust; Wrightington, Wigan and Leigh Teaching Hospitals NHS FT; The Newcastle upon Tyne Hospitals NHS Foundation Trust; Swansea Bay University Health Board; Sherwood Forest Hospitals NHS FT; United Lincolnshire Hospitals NHS Trust; Northampton General Hospital NHS Trust; Cardiff and Vale University Local Health Board

Summary: LOVE-DEB is a UK-based prospective registry evaluating the real-world safety and efficacy of the SELUTION SLR™ sirolimus drug-eluting balloon (DEB) in patients with de novo native coronary artery disease affecting large vessels (≥ 2.75 mm). The primary outcome is the rate of target lesion revascularisation within 12 months following percutaneous coronary intervention (PCI).

The SELUTION SLR™ DEB, which received CE Mark approval in May 2020, is currently commercially available in Europe, Asia, the Middle East, and other regions recognising the CE mark. This study is among the first to examine the clinical use of sirolimus DEBs specifically in larger coronary vessels under routine clinical conditions.

Over 300 participants have been enrolled across 10 centres in the UK. The study will contribute important data on the performance of sirolimus DEBs as an alternative to stent implantation, potentially shaping future clinical practice.

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