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New balloon treatment shows promise for unclogging large heart arteries

NCT ID NCT05915468

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

306 people

The number who actually took part.

Started

Jul 2023

Finished

Dec 2025

Lead sponsor

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

18 years and older

Sex

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

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

  • Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust

    Wigan, WN1 2NN, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.