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Balloons vs stents: new heart artery study could change treatment

NCT ID NCT07552194

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests if using only drug-coated balloons is as safe and effective as stenting for treating blocked heart arteries at branch points. About 272 people with chronic coronary syndrome will be randomly assigned to one of the two treatments. Researchers will track deaths, heart attacks, and the need for repeat procedures over 12 months.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 272 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

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.

Ages

18 to 80 years

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 with CCS with documented myocardial ischemia in area supplying by the target coronary artery, not older than 80 years and with an expected life expectancy of at least 1 year * Patients with single- or multivessel disease and "true" (1.1.1; 1.1.0; and 0.1.1 according to the Medina classification) de novo bifurcation stenosis \> 50% and \<100% of the main coronary artery (excluding of the left main) or their large side branches. * Both main and side branches should be ≥ 2.0 mm and ≤ 4.5 mm in diameter (according to Quantitative coronary angiography - QCA or intravascular imaging) * Length of the main branch lesion should be no more than 30 mm * The total length of the side branch should be no more than 7 cm, and the side branch lesion length should be no more than 10 mm * Patients without hereditary coagulopathies * With a recent (at least 3 months) history of acute coronary syndrome (ACS) * Signed informed consent by patient to participate in the study Exclusion Criteria: * Patients with a single remaining artery supplying a large area of myocardium at risk, regardless of its caliber * Over 80 years of age * Bifurcation stenosis of the left main coronary artery and bifurcation lesions other than 1.1.1; 1.0.1, and 0.1.1 according to the Medina classification * The difference between the proximal and distal reference diameter of the main artery is \> 1 mm * Pregnancy or breastfeeding * Severe valvular heart disease requiring surgical or percutaneous intervention within 1 year * Life expectancy less than 1 year. * Chronic renal failure (glomerular filtration rate less than 30 ml/min) * Concomitant cancer * Heart failure \> NYHA class II * In-stent restenosis in bifurcation lesions after previously performed PCI * Presence of thrombus containing Lesion * Without concomitant chronic occlusion (bifurcation included in the chronic coronary occlusion (CTO)) * Patients at high bleeding risk (according to the PRECISE-DAPT score) * LV ejection fraction according to echocardiography ≤ 0.4 * Anemia (Hb \< 10 g/dL) * Thrombocytopenia and any coagulopathy * Episodes of significant bleeding and ongoing bleeding requiring modification of medical therapy * Acute coronary syndrome * PCI or coronary artery bypass grafting (CABG) performed according to clinical indications * Patient non-adherence to therapy, including antiplatelet and/or anticoagulant medications

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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.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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