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

• ClinicalTrials.gov Identifier: NCT05915468
• Recruitment Status: Recruiting
• First Posted: June 23, 2023
• Last Update Posted: August 2, 2023
• Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust
• Collaborator: Professor Azfar Zaman - Freeman Hospital, Newcastle
• Information provided by (Responsible Party): Wrightington, Wigan and Leigh NHS Foundation Trust

Tracking Information

• First Submitted Date: December 6, 2022
• First Posted Date: June 23, 2023
• Last Update Posted Date: August 2, 2023
• Actual Study Start Date: July 12, 2023
• Estimated Primary Completion Date: July 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2023)

Subject evaluation - Evaluate the proportion of subjects that underwent Target Lesion Revascularization (TLR) within 1 year of baseline PCI [ Time Frame: 12 months ]

Determined by percutaneous or surgical methods

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 19, 2023)

• Patient reported recurrence of Angina [ Time Frame: 12 months ]
  Assessed using the SAQ-7 questionnaire performed at baseline and via the telephone
• All cause mortality [ Time Frame: 12 months ]
  Cause of mortality

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Large De-NOVo Coronary artEry Disease Treated With Sirolimus Drug Eluting Balloon (LOVE DEB)
• Official 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 (LOVE-DEB Registry)

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.

Detailed Description

This study is a prospective, observational, multicentre, single-arm registry designed to evaluate the clinical safety and performance of SELUTION SLR, Sirolimus-eluting balloon (SEB). The study population is made up of subjects who have undergone PCI using SELUTION DEB and are receiving standard of care (as per national guidelines). Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure. Rationale for this study is to assess the safety and efficacy of SELUTION SLR, a sirolimus DEB, in larger vessels. The current evidence base for the safety & efficacy of sirolimus DEB in coronary vessels greater or equal 2.75mm is limited.

After an eligible subject has been treated with the SELUTION DEB, informed consent will be requested and the patient registered in the study. The study does not influence the choice of device utilised nor does it alter the routine standard of care.

Baseline data will be completed using medical notes and a baseline questionnaire will be completed by the subject. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days and 12 months from the baseline PCI procedure date.

Potential subjects will be approached for informed consent after they have had a PCI procedure. They will be given the opportunity to ask any questions that they wish and given an appropriate amount of time to consider. Following registration, the baseline medical information will be collected from medical records and the subject will be asked to complete the SAQ-7 questionnaire.

The GP will be contacted to determine the survival status of the subject at 30 days (+/- 7 days) and 12 months (+/- 30 days) follow up, timed from date of baseline PCI. 30 day and 12 month follow up will done via the telephone and will consist of a verbally reported angina status assessment, recording of any adverse events, concomitant antiplatelet / anticoagulation medications and any interventional treatment that has occurred since previous contact. If the subject reports having angina at the 12 month time point then they will be asked to respond to the SAQ-7 questions over the phone.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Biospecimen: Not Provided
• 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)
• Condition: Coronary Artery Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 19, 2023): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2026
• Estimated Primary Completion Date: July 1, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Abhishek Kumar; 01257 567204; abhishek.kumar@wwl.nhs.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT05915468
• Other Study ID Numbers: LOVE-DEB
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Wrightington, Wigan and Leigh NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust
• Original Study Sponsor: Same as current
• Collaborators: Professor Azfar Zaman - Freeman Hospital, Newcastle
• Investigators: Not Provided
• PRS Account: Wrightington, Wigan and Leigh NHS Foundation Trust
• Verification Date: June 2023