Coronary Artery DiseaseNCT05915468
Large De-NOVo Coronary artEry Disease Treated With Sirolimus Drug Eluting Balloon (LOVE DEB)
An observational study of Coronary Artery Disease, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 306 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2023to 11 Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN1 2NN
About this study
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)
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Patient reported recurrence of Angina
Assessed using the SAQ-7 questionnaire performed at baseline and via the telephone
Measured: 12 months
All cause mortality
Cause of mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start12 Jul 2023
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915468
- Sponsor's protocol ID
- LOVE-DEB
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05915468
- Acronym / sponsor ID
- LOVE-DEB
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Patient reported recurrence of Angina
Time frame: 12 months
All cause mortality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject evaluation - Evaluate the proportion of subjects that underwent Target Lesion Revascularization (TLR) within 1 year of baseline PCI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.