Balloons vs stents: new heart artery study could change treatment
NCT ID NCT07552194
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 272 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- 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.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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