Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older at the time of enrolling in the trial.
• People who have been diagnosed with a large bulge (aneurysm) in the major blood vessel of the chest and/or abdomen that requires a specific type of internal repair using a custom-fitted device delivered through a tube 18 French (about 6mm) or larger in diameter.
• People whose hip/groin arteries (iliac arteries) are difficult to access due to heavy calcium buildup around the full circumference of the artery, a very narrow inner width (6mm or less), or significant blockage reducing blood flow.
• People whose aneurysm repair is needed urgently, is planned in advance (elective), is causing symptoms, or where the aneurysm is growing quickly.
• People whose procedure involved the use of a Shockwave™ device to treat the calcified arteries before the main repair device was inserted, with or without additional balloon widening or stent placement.

Who may not be able to join:

• People who had a surgical bypass procedure (a detour route surgically created to go around a blocked artery) to allow access for the repair.
• People whose arteries do not have severe calcium buildup, or have no calcium buildup at all.
• People who have a blockage or narrowing inside a previously placed stent in the relevant artery.
• People whose arteries could not be crossed with a very fine guidewire (a thin wire used to guide medical devices) during the procedure.
• People with a significant medical condition that, in the opinion of the medical team running the trial, could affect safe participation.
• People who already had a stent placed in the hip/groin arteries at the site where the Shockwave™ device would be used.

Important: Always verify eligibility with the trial site directly before applying.