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 who have peripheral artery disease (PAD) in their legs that has progressed to a serious stage called chronic limb-threatening ischemia (CLTI) — meaning they have foot pain at rest, wounds that are not healing, or gangrene that has been present for at least two weeks, and where blood flow problems have been confirmed by medical testing
• People whose blood pressure measurements at the ankle or toe fall below certain low thresholds (specific numbers vary depending on whether the main problem is pain at rest or tissue damage), confirming that blood flow to the foot is severely reduced
• People who are scheduled to have a procedure to restore blood flow through a blood vessel using a non-surgical, catheter-based approach
• People who have provided their informed consent to take part in the trial
• People who have imaging (such as an X-ray dye study, ultrasound, CT, or MRI) showing a blockage or severe narrowing (more than 70%) in the leg arteries below the groin
• People whose blocked artery below the knee is located in the upper two-thirds of that vessel, and where the vessel measures more than 2.5mm wide as estimated by the treating doctor
• People where the furthest point of the blocked area is located more than 10cm above the ankle joint, and where the vessel from that point down to the ankle is open and clear of significant blockages

Who may not be able to join:

• People with physical, health, social, or psychological conditions that, in the investigator's opinion, would make it difficult for them to take part in or complete the trial's follow-up visits
• People whose medical condition means that a catheter-based procedure to restore blood flow is not medically suitable
• People who have previously had, or are scheduled to have, a surgical procedure to restore blood flow in the same blood vessel being treated in the same leg
• People who are confined to bed or completely unable to walk (note: walking with assistance is acceptable)
• People whose life expectancy is estimated to be less than 12 months
• People under 18 years of age
• People with active inflammation of the blood vessels (vasculitis), a condition called Buerger's disease, or a sudden severe loss of blood flow to a limb
• People who are planned to have an amputation above the ankle of the affected leg within four weeks of the procedure
• People who have a significant blockage (more than 70%) in the arteries higher up (above the groin) that is not planned to be treated at the time of the procedure or within 30 days of it
• People who have previously had an amputation of the same leg at a level higher than the toes or front of the foot, or who had a major amputation of the other leg less than one year ago and are not able to walk independently
• People whose tissue damage is so extensive that it would require complex foot reconstruction or certain types of major foot amputations — this includes specific situations such as:
  • Bone infection (osteomyelitis) extending beyond the base of the toes
  • Gangrene affecting the sole of the foot, the middle of the foot, or the heel
  • Deep wounds or large shallow wounds (larger than 3cm) on the sole of the foot, mid-foot, or heel
  • Full-thickness wounds on the heel
  • Any wound involving the heel bone
  • Wounds requiring surgical skin flap procedures or complex management due to large areas of tissue loss
  • Full-thickness wounds on the top of the foot where tendon or bone is exposed

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