Plain-English translation of NCT06657833 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.
When calcified (hardened) blockages form in heart arteries, doctors sometimes use a procedure called intravascular lithotripsy — essentially sound waves — to break up the calcium. After that, this trial is testing whether it's better to then use a drug-coated balloon or a drug-coated stent (a tiny mesh tube) to keep the artery open. Researchers want to know which approach works better and is safer for people with this type of blockage.
Calcified blockages in heart arteries are particularly tricky to treat because hardened calcium can prevent stents from expanding fully and staying in place properly. This study exists to find out whether the newer approach of using a drug-coated balloon alone might work just as well — or even better — than placing a stent, especially after the calcium has been softened with sound wave therapy.
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If you enroll, you will first undergo the intravascular lithotripsy procedure to break up the calcium in your artery blockage. Then you will be randomly assigned to receive either a drug-coated balloon or a drug-coated stent to keep the artery open. You will need to take blood-thinning medications for at least one month and return for follow-up imaging at 6 months to measure how well your artery is healing. The trial will track 128 participants total across multiple centers.
AI-generated summary from trial data · Jun 22, 2026 · Not medical advice
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