Compare shockwave balloon versus standard balloon for TAVI access
Part of Hormones & metabolism clinical trials.
This trial tests whether a shockwave balloon placed through the femoral (groin) artery works better than the standard balloon approach during TAVI in people with difficult, heavily calcified leg/artery access. It may help improve the success and safety of getting instruments through the groin when arteries are “stiff and narrowed.”
Summary written for real people, not researchers, by Clin2.
Who can take part
- You’re over 18 and can give written consent.
- You have severe aortic stenosis with symptoms and are planning TAVI (heart valve replacement) with your heart team.
- Your scan shows severe, calcified peripheral artery disease (leg artery disease) with challenging femoral access.
- Your CT/measurements must meet specific artery size and blockage “scores” (includes ref measurement and minimum lumen).
- You can’t have limited life expectancy (less than 1 year) or an active infection needing antibiotics.
- Your health situation allows standard blood-thinning medicines (no contraindication) and you’re not allergic to the contrast dye or procedure medicines.
- You haven’t had recent artery procedures on the same leg (within 30 days) and no major amputation is planned soon.
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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