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LOVE-DEB

Disease area: Coronary Heart Disease

Status: Actively recruiting

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

Trial Objective: The objective of this Registry is to evaluate the safety and efficacy of SELUTION SLRTM, a Sirolimus Drug Eluting Balloon (DEB), in treating de novo native coronary artery disease in larger vessels (≥ 2.75 mm). The primary objective is to evaluate the proportion of subjects who underwent Target Lesion Revascularization within 1 year of the baseline PCI.

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

Co-Chief Investigator (CI):  Prof Azfar Zaman, Consultant Interventional Cardiologist, Freeman Hospital, Newcastle Upon Tyne

Sponsor: Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust. For further information, please contact: Helen Spickett, Research Sponsorship Manager        Helen.Spickett@wwl.nhs.uk

Trial Management: CVCTU Trial Coordinator LOVE-DEB-CVCTU@qmul.ac.uk

IRAS Number :313203

Sponsor (RPEAK) Number: 1242

REC Reference: 22/PR/1358

Summary: LOVE-DEB is a prospective study in the United Kingdom. The objective of this Registry is to evaluate the safety and efficacy of SELUTION SLRTM, a Sirolimus Drug Eluting Balloon (DEB), in treating de novo native coronary artery disease in larger vessels (≥ 2.75 mm).

The study’s primary objective is to evaluate the proportion of patients who underwent target lesion revascularization within 1 year of the procedure.

The SELUTION SLRTM DEB received CE Mark approval for the treatment of coronary artery disease in May 2020. The device is commercially available in Europe, Asia, the Middle East, and the Americas (outside the United States) and most other countries where the CE Mark is recognized.

The LOVE-DEB study is a unique trial in which the safety and efficacy of sirolimus DEB in de novo disease specifically in the large coronary arteries in routine clinical practice will be assessed. The aim is to recruit 300 patients across 10 centres in the United Kingdom.

Sample size and duration: 300 participants, 24 months

Enquiries: love-deb-cvctu@qmul.ac.uk; Helen.Spickett@wwl.nhs.uk

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