New balloon treatment shows promise for unclogging large heart arteries
NCT ID NCT05915468
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a special balloon coated with sirolimus, a drug that helps keep arteries open, to treat large blockages in the heart's blood vessels. Over 300 adults with coronary artery disease were treated and followed for one year to see if they needed another procedure to reopen the treated artery. The goal was to see how safe and effective this balloon is for managing heart disease.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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306 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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)
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust
Wigan, WN1 2NN, United Kingdom
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