Shockwave treatment for TAVR access site
Part of Heart & circulation clinical trials.
This trial tests if using Shockwave IVL to break up calcium in the groin artery before a TAVR procedure can improve outcomes. It may help patients with significant calcium buildup at the access site.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 years or older
- You have severe aortic stenosis and are scheduled for TAVR
- You can read and understand the study procedures
- You are willing to sign a consent form
- You have more than 90 degrees of calcium arch at the access site on a CT scan
- Your femoral artery calcium is in a favorable location for treatment
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
Similar studies
Other trials that look related to this one.
This trial tests a device called Shockwave M5+/L6 intravascular lithotripsy to help deliver stent grafts when the iliac (pelvic) arteries are extremely calcified and hard to access. It may help people who are being evaluated for endovascular (through-the-blood-vessel) treatment but whose anatomy makes standard access difficult.
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.”
This trial tests whether a treatment called intravascular lithotripsy (using sound waves from inside a blood vessel) can help widen severely calcified, narrowed iliac arteries so a TAVR procedure can be done through the groin. It may help some people who are considered “high risk” for access, based on CT scan findings.
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 trial tests a special balloon that uses shock waves to crack calcium in the iliac arteries, making room for a larger aortic stent graft. It is for people with a bulging aorta (aneurysm) who also have heavily calcified or narrow iliac arteries that would otherwise prevent the graft from passing through.
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.
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