Plain-English translation of NCT06657326 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Coronary Artery Disease research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
The LEADERS FREE IV trial is testing a newer version of the BioFreedom™ Ultra stent — a small wire mesh tube that doctors place in blocked arteries to keep them open — compared to the standard BioFreedom™ stent. Both stents release a medication over time to prevent the artery from becoming blocked again. This trial focuses on people who have a higher-than-average risk of bleeding, so doctors want to make sure the new version works just as well while keeping patients safe.
Patients with high bleeding risk often need heart stents but face a tougher choice because blood-thinning medications required after stent placement can increase their bleeding risk. This trial exists to confirm that the newer version of this treatment is just as effective as the current version, so doctors can confidently offer it to patients who need extra caution around bleeding.
You likely qualify if…
You likely don't qualify if…
If you qualify and are randomly assigned to the trial, you will undergo a procedure called percutaneous coronary intervention (PCI), where doctors insert a catheter into your artery and place one of the two stents to open your blocked artery. You will receive one type of stent or the other — determined randomly — and neither you nor some of the study staff will know which one you got. After the procedure, you will take blood-thinning medications as prescribed and return for follow-up visits at 9 months and then periodically for up to 5 years so doctors can monitor how well the stent is working and check for any safety concerns.
AI-generated summary from trial data · Jul 1, 2026 · Not medical advice
Malaysia