Evaluating a new balloon treatment for coronary artery disease
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)
This study is testing a new balloon treatment for coronary artery disease to see if it is safe and effective for people with larger blood vessels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wrightington, Wigan and Leigh NHS Foundation Trust Academic / other |
| Locations | 1 site (Wigan) |
| Trial ID | NCT05915468 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the safety and efficacy of the SELUTION SLR, a Sirolimus Drug Eluting Balloon (DEB), in treating de novo native coronary artery disease in larger vessels (≥ 2.75 mm). Patients who have undergone percutaneous coronary intervention (PCI) using the SELUTION DEB will be enrolled after providing informed consent. The study will collect baseline data and follow-up information at 30 days and 12 months post-procedure to evaluate the proportion of subjects requiring Target Lesion Revascularization (TLR). This research is crucial as current evidence on the use of sirolimus DEB in larger coronary vessels is limited.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who have undergone PCI for de novo coronary lesions with a vessel diameter of at least 2.75 mm.
Not a fit: Patients with ST Elevation Myocardial Infarction (STEMI) or those requiring urgent PCI are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with coronary artery disease.
How similar studies have performed: While this approach is based on existing technologies, the specific application of sirolimus DEB in larger vessels is less explored, making this study somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
Wigan
- Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust — Wigan, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Abhishek Kumar
- Email: abhishek.kumar@wwl.nhs.uk
- Phone: 01257 567204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.