Large De-NOVo Coronary artEry Disease Treated With Sirolimus Drug Eluting Balloon (LOVE DEB)

NCT05915468 | Completed

• 1 other identifier: LOVE-DEB
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this post-market Registry is to evaluate the safety and efficacy of SELUTION SLR, a Sirolimus Drug Eluting Balloon (DEB), in treating de novo native coronary artery disease in larger vessels (≥ 2.75 mm). This is a post-market registry that collects the data of patients who have been treated with a SELUTION DEB. The primary objective is to evaluate the proportion of subjects who underwent Target Lesion Revascularization (TLR) within 1 year of the baseline PCI.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Subject evaluation - Evaluate the proportion of subjects that underwent Target Lesion Revascularization (TLR) within 1 year of baseline PCI

  Determined by percutaneous or surgical methods

  12 months

Secondary Outcomes (2)

• Patient reported recurrence of Angina

  12 months

• All cause mortality

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is made up of patients who have undergone PCI using SELUTION DEB and are receiving standard of care (as per national guidelines)

You may qualify if:

• Patients aged 18 years or older
• Patients who have undergone PCI of at least one de-novo coronary lesion confirmed on coronary angiography using SELUTION SLR DEB, within 7 days prior to study registration.
• Vessel diameter must be ≥ 2.75 mm
• Bifurcation lesions: where main branch ≥ 2.75 mm and a DEB only strategy was applied in at least the main branch.
• Patients who give informed consent for participation in the study.

You may not qualify if:

• Patients with ST Elevation Myocardial Infarction (STEMI)
• Patients with cardiogenic shock.
• Patients who need urgent PCI following out of hospital cardiac arrest
• Patients with Left Main Stem or distal Left Main Stem bifurcation disease
• Patients with history of previous coronary revascularisation (PCI or CABG) prior to the baseline PCI
• Patients requiring calcium modification with rotational, orbital or laser atherectomy or intra-vascular lithotripsy (IVL)
• Patients with in-stent restenosis (ISR)
• Patients with Chronic Total Occlusions (CTO)
• Vessel diameter less than 2.75 mm
• Bifurcation lesion treated with stent (either main or side branch)
• Patients who have undergone cardiac transplant
• Patients with history of malignancy and life expectancy less than 12 months
• Patients who are pregnant or possibly pregnant.
• Patients have a known hypersensitivity or contraindication to Aspirin, Clopidogrel, Heparin or any other anticoagulation / antiplatelet therapy required for PCI, Sirolimus or contrast media.
• Patients scheduled to undergo elective surgery within 1-month post-index PCI.

Sponsors & Collaborators

• Wrightington, Wigan and Leigh NHS Foundation Trust: lead

Study Sites (1)

Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust

Wigan, WN1 2NN, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: June 23, 2023
• Study Start: July 12, 2023
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)