Balloon vs stent: new hope for heart patients with multiple blockages?
NCT ID NCT07539324
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug-coated balloon is as good as or better than a drug-eluting stent for people with multiple blocked heart arteries. About 892 adults with stable heart disease or recent heart attack will be randomly assigned to one of the two treatments. The goal is to see which approach leads to fewer deaths, heart attacks, repeat procedures, or bleeding events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paclitaxel-coated balloon catheter
- What this could lead to
- If successful, this could offer a stent-free option for treating multiple blocked heart arteries, potentially reducing long-term complications like bleeding.
- What could go wrong
- This is an early-stage trial not yet recruiting, and the balloon approach may not be as effective as stents for keeping arteries open long-term.
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
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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 892 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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20 years and older
- 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: 1. Male or female adults aged 20 years or older with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI). 2. In cases of ST-segment elevation myocardial infarction (STEMI), patients who have undergone successful primary percutaneous coronary intervention (PCI) without complications, at least 48 hours post-procedure, and whose target lesion(s) show no evidence of thrombus. 3. Patients with multivessel coronary artery disease, defined as angiographic stenosis of 50% in at least two major epicardial coronary arteries requiring PCI as determined by the investigator. 4. Reference vessel diameter (RVD) of the target lesion(s) between 2.25 mm and 4.0 mm by visual estimation or quantitative coronary angiography (QCA). 5. Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB). 6. Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements. Exclusion Criteria: 1. Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support. 2. Patients with a life expectancy of less than 2 years due to comorbid conditions. 3. Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies. 4. Women who are pregnant or have childbearing potential. 5. Patients with a known hypersensitivity or allergy to contrast media, L-605 Cobalt-Chromium (Co-Cr) alloy, PLA and PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus. 6. Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft. 7. Patients with target vessels/lesions that are excessively tortuous, angulated, or severely calcified, such that pre-dilatation cannot be performed or has failed, making the application of the investigational medical device difficult.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New Stent-Like device aims to adapt to heart arteries
- A shot of nicorandil before stenting might keep blood flowing
- Can a common gout pill shield hearts after stents?
- A 7,000-Person trial asks: is lifelong aspirin necessary for older hearts?
- Which strategy wins for heart attack patients with multiple blocked arteries?
- Can a tailored Blood-Thinner combo prevent second heart attacks without causing bleeding?