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:

• You have a blocked femoral artery in your leg and need planned surgery to reroute blood flow above the knee (called a femoral popliteal bypass)
• Your leg circulation problem has been rated at a specific level of severity (Rutherford grade 3, 4, or 5), and your blockage is classified as a more complex type (TASC C or D lesion)
• If you have a grade 5 rating, you may still be eligible if you have a wound or foot infection of limited severity, and at least two blood vessels are still open in the lower leg reaching the foot (confirm with trial site)
• You are at least 18 years old
• Your blood vessels have been assessed as having suitable anatomy, confirmed by a CT scan with contrast dye or an angiogram taken within the last 90 days
• You are willing to give written consent after being fully informed about the study
• You agree to attend all required check-ups before and after the procedure, including follow-up imaging
• You are expected to live for at least 24 months

Who may not be able to join:

• You need or are scheduled for heart surgery or a different blood vessel surgery within 30 days of this procedure
• You have had a previous bypass surgery in the affected leg
• You need multiple procedures to restore blood flow in the same limb, or other procedures requiring additional vascular grafts
• You have had a stroke or heart attack within the last 6 weeks, or have had a severe stroke in the past that significantly affects your daily function
• You have a history of a sudden, severe artery blockage that needed emergency treatment
• You have serious kidney disease (with a specific blood marker above a set level) or are on dialysis
• You have had a kidney transplant
• You have very high blood pressure that is not controlled (above 200 mmHg on two separate readings)
• You have diabetes that is not well controlled
• You have abnormal blood test results that could affect your recovery or how well the graft works (confirm with trial site)
• You have reduced liver function shown by specific blood test results being above acceptable levels
• You have any active infection, either in one part of your body or throughout your whole body
• You have a condition where heparin (a blood-thinning medication) has caused a dangerous drop in your platelet levels in the past
• You have an active bleeding disorder, a blood clotting problem, or a condition where blood clots form abnormally
• You have known allergies to the device material (a metal called nitinol), contrast dye used in imaging, or aspirin, that cannot be managed with medication
• You have previously taken part in this same study
• You are currently taking part in another clinical study
• You are pregnant, breastfeeding, or are able to become pregnant and are not using adequate contraception
• Your doctor decides there is any other reason that would make it unsafe or unsuitable for you to take part (confirm with trial site)
• During surgery, if your blood vessels are found to be a different size than expected or too heavily calcified, you may not be able to receive the study device

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