Stents plus drugs vs. drugs alone: which is better for heart failure?
NCT ID NCT07349979
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two approaches for people with heart failure and narrowed heart arteries: a stent procedure plus guideline-directed medications versus medications alone. About 1,150 participants will be followed for at least two years to see which group has fewer major heart problems like heart attacks, hospitalizations, or death. The goal is to find out if adding a stent improves outcomes beyond what medications can achieve.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- heart stent procedure (percutaneous coronary intervention) plus standard heart failure medications
- What this could lead to
- If it works, this could show that combining stents with medications is better than medications alone for preventing heart attacks, hospitalizations, and death in people with heart failure.
- What could go wrong
- This trial hasn't started yet, so results are years away. The procedure carries risks like bleeding or vessel damage, and the benefit over medications alone may be small or absent.
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 1,154 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 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 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. Age ≥18 years at screening. 2. Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization. 3. Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg/mL. 4. Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (\>80%) of PCI success, or 3) a visually estimated DS of \<90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist. 5. On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site. 6. The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures. Exclusion Criteria: 1. Class III or IV angina requiring revascularization. 2. Any unplanned hospitalization within 30 days. 3. Any PCI within 12 months. 4. Any prior CABG. 5. Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate) 6. Non-cardiac life expectancy \<1 year at screening (e.g., malignancy, advanced liver disease). 7. Coronary anatomy requiring surgical revascularization by local heart team determination. 8. Coronary anatomy unsuitable for PCI. 9. HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM). 10. Severe stenosis or regurgitation of any heart valve. 11. Contraindication to dual antiplatelet therapy or iodinated contrast. 12. Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential. 13. Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol. 14. Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006, China
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