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 years or older.
• People (or their legal representative) who understand what the procedure involves and are willing to sign a consent form before the study begins.
• People with a disease of the aorta (the body's main artery) who need a type of minimally invasive surgery called endovascular treatment, but where standard treatment is considered too difficult because the blood vessels in the pelvis (iliac arteries) are heavily calcified (hardened with calcium deposits) and the device used for the procedure may be too large for the vessel.
• People where the size of the surgical device is more than 20% larger than the narrowest part of the vessel it needs to pass through (confirm with trial site).
• People with a high level of calcium buildup in the walls of the iliac arteries, covering more than half the artery's inner wall (graded 3 or 4 on a specific calcium scoring scale).
• People with calcified blockages in the iliac arteries that total more than 20mm in combined length, measured from a specific point near the lower abdomen down to the top of the thigh artery.
• People whose condition makes them suitable for treatment with a specific medical device called the Shockwave M5+ IVL system, as determined by the treating doctor.
• People with aortic disease needing endovascular treatment, who may or may not also have reduced blood flow in the legs (classified at a certain severity level using a standard medical scoring system).
• People who are able and willing to attend follow-up appointments as required by the study schedule.

Who may not be able to join:

• People who have a complete blockage in both iliac arteries at the same time.
• People who need urgent treatment due to a blood clot in the iliac artery causing sudden loss of blood flow to the limb.
• People who are in an unstable medical condition at the time of the procedure.
• People who do not wish to receive treatment.
• People for whom blood-thinning medications (such as antiplatelet drugs, anticoagulants, or clot-dissolving drugs) are not medically safe to use.
• People who have previously had a severe, life-threatening reaction to the contrast dye used in imaging procedures.
• People whose life expectancy is less than twelve months.

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