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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05915468
Recruitment Status : Recruiting
First Posted : June 23, 2023
Last Update Posted : August 2, 2023
Sponsor:
Collaborator:
Professor Azfar Zaman - Freeman Hospital, Newcastle
Information provided by (Responsible Party):
Wrightington, Wigan and Leigh NHS Foundation Trust

Study Description
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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.


Condition or disease
Coronary Artery Disease

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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)
Actual Study Start Date : July 12, 2023
Estimated Primary Completion Date : July 1, 2025
Estimated Study Completion Date : July 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Patient reported recurrence of Angina [ Time Frame: 12 months ]
    Assessed using the SAQ-7 questionnaire performed at baseline and via the telephone

  2. All cause mortality [ Time Frame: 12 months ]
    Cause of mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05915468


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

Locations
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United Kingdom
Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust Recruiting
Wigan, United Kingdom, WN1 2NN
Contact: Abhishek Kumar       abhishek.kumar@wwl.nhs.uk   
Sponsors and Collaborators
Wrightington, Wigan and Leigh NHS Foundation Trust
Professor Azfar Zaman - Freeman Hospital, Newcastle
More Information
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Responsible Party: Wrightington, Wigan and Leigh NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05915468    
Other Study ID Numbers: LOVE-DEB
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: August 2, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases