Clin2
NCT05880641Possibly a fitRecruiting

Shockwave balloon treatment for very hard, blocked iliac arteries

Aortic DiseasesAorto-Iliac AtherosclerosisPeripheral Arterial Disease

Part of Heart & circulation clinical trials.

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.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
40 people
Ages
18 years and older
Study type
Observational

Who can take part

  • You are age 18 or older, and you (or your legal representative) can sign consent before the procedure.
  • Your doctors plan an endovascular treatment for an aortic condition, but it seems too difficult because your iliac arteries are severely hardened with calcium.
  • Your iliac artery blockage includes a calcified area longer than 20 mm (from the aortic fork down toward the upper thigh artery).
  • Your calcification is severe (calcium grade 3 or 4), and your artery measurements fit the device’s intended use.
  • You are able to take blood-thinning medicines (antiplatelet and/or anticoagulants) or alternatives are allowed by the protocol, and you can follow up for the study.

View the official record on ClinicalTrials.gov

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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