Phase 4 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:

Main (Randomised Controlled) Trial:

• People aged 18 or older.
• People with a life expectancy of at least one year.
• People who are able and willing to take part in all required study visits and assessments.
• People who have been fully informed about the study and have signed a consent form agreeing to take part.
• People whose affected leg has been classified as Rutherford Category 4 or 5 (meaning they have rest pain or minor tissue loss/wounds due to poor blood flow).
• People whom the treating doctor or hospital considers suitable for an angiogram (an X-ray of the blood vessels) and a procedure to open the blood vessel from the inside.
• People with a blockage or narrowing located in a specific section of a leg artery below the knee (from the lower part of the popliteal artery down to the ankle).
• People whose target narrowing or blockage is between 50% and 100% blocked, as seen on an angiogram.
• People with only one target lesion (area of narrowing) in the study.
• People where the blood vessel beyond the target area is open and unobstructed all the way to the ankle.
• People whose target lesion (narrowing) is at least 50mm long and no more than 300mm long.
• People where the guidewire used during the procedure can be successfully passed through the blockage without causing serious complications.
• People whose affected blood vessel measures between 1.5mm and 4.5mm in diameter, as estimated by the treating doctor.

Observational Study (for those who do not qualify for the main trial):

• People intended to be treated with the Auryon Atherectomy System for new or previously treated blockages in the arteries below the knee.
• People who have symptoms of peripheral artery disease (poor blood flow to the legs) rated as Rutherford Category 2 through 6 (ranging from mild symptoms when walking to severe limb-threatening conditions).
• People aged 18 or older.
• People who have been fully informed about the study and have signed a consent form agreeing to take part.

Who may not be able to join:

Main (Randomised Controlled) Trial:

• People whose target blockage is inside an artificial or synthetic blood vessel graft.
• People where the procedure would be performed via the wrist (radial access).
• People for whom a major amputation above the ankle of the affected leg is already planned.
• People with sudden (acute) limb-threatening loss of blood flow, or who needed clot-dissolving treatment as their main treatment.
• People who had any procedure (surgical or endovascular) on the affected leg within 30 days before joining the study, or who have one planned within 30 days after the study procedure.
• People who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test within 7 days before the procedure.
• People with a known blood clotting disorder or a very low platelet count (below certain thresholds that affect the blood's ability to clot).
• People for whom blood-thinning or anti-clotting medications are not medically suitable.
• People with a known allergy to the contrast dye used during the procedure, or to medications used during the procedure, that cannot be adequately managed beforehand.
• People who had a heart attack within the 60 days before joining the study.
• People who had a stroke or mini-stroke (TIA) within the 60 days before joining the study.
• People who received clot-dissolving therapy within 14 days before joining the study.
• People with significant kidney disease (defined by specific blood test results) or who are on dialysis.
• People currently participating in another research study involving an investigational drug, biological agent, or medical device that has not yet reached its main outcome point.
• People who, in the treating doctor's opinion, have medical, social, or psychological conditions that would make participation unsuitable.
• People with ongoing heart problems that the treating doctor considers would make the procedure unsuitable.
• People with evidence of bleeding in the brain or digestive system within the past 3 months.
• People where significant blockages in related arteries leading to the target area (in the hip, thigh, or upper knee region) could not be successfully treated before the study procedure.
• People where complications (such as a clot or tear in the blood vessel) occurred before the study device was used.
• People where devices other than the study laser catheter and/or standard balloon catheters were needed to treat the target blockage (with a limited exception for certain stents used in an emergency situation).

Observational Study:

• People with a medical condition that the treating doctor or the device's instructions for use consider unsuitable for treatment with the Auryon Atherectomy System.
• People who are pregnant or breastfeeding. Women of childbearing age must have a negative pregnancy test within 7 days before the procedure.
• People already enrolled in another interventional research study that could interfere with this study's results.

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