NCT05915468Completed
Large De-NOVo Coronary artEry Disease Treated With Sirolimus Drug Eluting Balloon (LOVE DEB)
Large De-NOVo Coronary artEry Disease Treated With Sirolimus Drug Eluting Balloon: Prospective Evaluation of Safety & Efficacy of SELUTION SLR TM Drug Eluting Balloon (LOVE-DEB Registry)
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 306 (actual)
- First submitted
- 6 Dec 2022
- Start date
- 12 Jul 2023
- Primary completion date
- 11 Dec 2025
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Diseases
- Coronary artery disease
- NCT number
- NCT05915468
What you commit to
- Study type: Observational
- Participants enrolled: 306
- From 12 Jul 2023 to the primary completion date, 11 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with history of previous coronary revascularisation (PCI or CABG) prior to the baseline PCI
- Bifurcation lesion treated with stent (either main or side branch)
- Patients scheduled to undergo elective surgery within 1-month post-index PCI.
- Patients who are currently participating in a clinical study of another drug or medical device and in whom assessment of the primary endpoint of that study has not been completed or clinically interferes with the endpoints of this registry.
Other illness
- Patients with ST Elevation Myocardial Infarction (STEMI)
- Patients who need urgent PCI following out of hospital cardiac arrest
- Patients with Left Main Stem or distal Left Main Stem bifurcation disease
- Patients who have undergone cardiac transplant
- Patients with history of malignancy and life expectancy less than 12 months
- Patients have a known hypersensitivity or contraindication to Aspirin, Clopidogrel, Heparin or any other anticoagulation / antiplatelet therapy required for PCI, Sirolimus or contrast media.
Lab values
- Patients requiring calcium modification with rotational, orbital or laser atherectomy or intra-vascular lithotripsy (IVL)
Other
- Patients with cardiogenic shock.
- Patients with in-stent restenosis (ISR)
- Patients with Chronic Total Occlusions (CTO)
- Vessel diameter less than 2.75 mm
- Patients who are pregnant or possibly pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Wigan | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.