Test shockwave and drug-coated balloon for blocked arteries
Part of Heart & circulation clinical trials.
This study tests a device approach called Shockwave IVL followed by a drug-coated balloon to treat hard, calcified coronary (heart) artery blockages. It may help improve how well the artery stays open after treatment.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be 18 years old or older.
- You have coronary artery disease where a stent procedure is planned to treat one or more blocked areas.
- The blocked artery area must be a new (de novo) blockage, narrowed more than 50%, in a smaller vessel under 3.0 mm, with heavy calcium.
- The target blockage must be the main area you plan to treat (it should not be near a prior stent/previous intervention within 10 mm).
- The blockage should be less than 40 mm long and not involve a fork in the artery (not a bifurcation).
- Your doctor should not plan atherectomy or cutting/scoring balloons, and the area should not contain clot.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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This trial tests a new device that uses sound waves to break up calcium deposits in heart arteries before placing a stent. It is for people with severely hardened arteries that are hard to treat with standard methods.
This registry studies how a device called Shockwave IVL (intravascular lithotripsy) is used to treat hard, calcified blockages in heart arteries when a stent is needed. It mainly helps doctors track outcomes and safety over follow-up.
This trial compares two treatments for heavily calcified heart artery blockages: a special balloon that uses sound waves to break up calcium (lithotripsy) versus a standard balloon. It also looks at whether using a camera inside the artery (OCT) helps guide the procedure.
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