Balloon vs stent: new heart artery trial aims for better outcomes
NCT ID NCT07582250
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a drug-coated balloon (DCB) to a drug-eluting stent (DES) for treating new blockages in heart arteries. About 1,548 adults with stable or unstable angina, old heart attacks, or silent ischemia will be randomly assigned to one of the two treatments. The main goal is to see which approach better prevents heart-related death, heart attacks, or the need for repeat procedures one year later.
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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 1,548 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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Dec 2030
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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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.
General Inclusion Criteria: 1. Patients aged ≥ 18 years and ≤ 80 years; 2. Patients with stable angina, unstable angina, old myocardial infarction, or asymptomatic myocardial ischemia with objective evidence; 3. Patients without contraindications to coronary revascularization (PCI or CABG); 4. Patients who can understand the study purpose, voluntarily participate in the trial, sign the informed consent form, and are willing to complete follow-up as required by the protocol. Angiographic Inclusion Criteria: 1. The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted). 2. All target lesions shall meet the following requirements: ① The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm; ② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence; ③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%. 3. Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation). 4. If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.
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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.