Peripheral Arterial Disease Trial, Completed

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:

• You are willing and able to take part in all parts of the study
• You (or your legal representative) have read, understood, and signed the consent form
• You are older than 18 years of age
• You have leg artery disease that causes symptoms ranging from mild leg cramping when walking to pain at rest or tissue loss, but not yet severe enough for major tissue death (confirm with trial site — based on a scale called Rutherford Category 2, 3, 4, or 5)
• Your doctors expect you to live for more than one year
• You are scheduled to be treated using a specific device called the Shockwave M5+ Peripheral IVL System for new (never previously treated) blockages in the large arteries of your hip, thigh, or knee area
• The blockage(s) being treated are located in the arteries running from your hip down to just below your knee, in one or both legs
• The affected artery is between 3.5mm and 8.0mm wide (as estimated visually by the doctor)
• The blockage narrows the artery by 70% or more
• If the artery is partially blocked (70–99%), the blocked section is no longer than 200mm in length
• If the artery is completely blocked, that fully blocked section is no longer than 100mm (within an overall treated area of up to 200mm)
• At least one artery below the knee on the treated leg remains open (less than 50% narrowed), allowing blood flow to reach the foot
• The blockage has at least a moderate amount of calcium buildup, confirmed by imaging (confirm with trial site for exact definition)

Who may not be able to join:

• Your leg artery disease falls into the mildest category (no symptoms) or the most severe category (major tissue death/gangrene) on the Rutherford scale (Categories 0, 1, or 6)
• You currently have an active infection that requires antibiotic treatment
• You have had a procedure (surgical or catheter-based) on the affected leg in the past 30 days, or one is planned within 30 days of this treatment
• You are unable to take blood-thinning or anti-clotting medications for medical reasons
• You have a known allergy to contrast dye or medications used during the procedure that cannot be managed with pre-treatment
• You have a known allergy to urethane, nylon, or silicone
• You have had a heart attack within the past 60 days
• You have had a stroke within the past 60 days
• You have significant kidney disease (based on a specific blood test result), unless you are already on dialysis
• You are pregnant or breastfeeding
• You are currently taking part in another research study involving an experimental drug, biologic, or device that has not yet completed its main goals
• Your doctor feels that other medical, social, or psychological factors make it unsafe or unsuitable for you to take part
• The treatment plan includes certain other specialised balloon or surgical devices in the blocked area (confirm with trial site)
• There is a previously placed stent that has re-narrowed within 10mm of the area to be treated
• The blockage is located below the knee joint
• There is evidence of a bulge (aneurysm) or blood clot in the artery being treated
• The blockage has little or no calcium buildup
• The blockage is inside a previously placed artificial or natural vessel graft
• You have more than three separate blockages requiring treatment
• There are other significant blockages in the same leg that were not successfully treated before this procedure
• The doctor is unable to pass a guidewire through the blockage during the procedure

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