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 symptoms of blocked or narrowed arteries in your legs that cause pain or cramping during activity or at rest (a condition rated at a moderate level of severity)
• Your doctor expects you to live for more than 36 months
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining
• You are able to understand and sign a consent form agreeing to take part in the study
• You agree to attend all required follow-up appointments at the study site
• You are able to take blood-thinning or anti-clotting medications as directed by your doctor
• You have a single new, untreated narrowed or blocked area in a specific artery in your thigh or upper knee area (the superficial femoral artery or the top section of the popliteal artery)
• The size of the artery being treated falls within a specific range (confirm with trial site)
• The blocked or narrowed section of the artery is no longer than 90 mm (roughly 3.5 inches)
• The artery is narrowed by at least 50% at the area being treated
• The arteries leading into and beyond the treated area do not have significant blockages themselves

Who may not be able to join:

• Your blood counts (red blood cells, white blood cells, or platelets) are outside of acceptable ranges (confirm with trial site)
• Your kidneys are not working well enough, based on a specific blood test result
• You have significant liver problems, based on specific blood test results
• You have a known allergy or serious reaction to certain medications used in this trial, including aspirin, heparin, bivalirudin, ticagrelor, sirolimus, or contrast dye used in imaging
• You need a planned surgery or procedure that would require you to stop taking blood-thinning medications
• You are unable to walk
• You have had a procedure to open a blocked blood vessel in the past 30 days
• You are currently on regular dialysis for kidney failure
• Your diabetes is not well controlled, based on a specific blood test (HbA1c of 7.0% or higher)
• You have had a heart attack in the past 30 days
• You have had a stroke in the past 30 days, or a previous stroke has already affected your ability to walk
• You have severe, unstable chest pain even while resting, with changes on a heart tracing (ECG)
• You have an active infection in the groin area or anywhere in your body that has not been successfully treated
• You have a blood clot or serious vein problems in either leg
• You have another serious illness (such as cancer or severe heart failure) that could affect your ability to complete the study or affect the results
• You are currently taking part in another clinical trial that could interfere with this one
• You have open sores or ulcers on either foot caused by poor circulation or nerve damage
• You have previously had part or all of either lower leg or foot amputated
• You are someone who, in the investigator's opinion, is not able to give fully informed consent
• There are other significant blockages further down the leg in the same limb that also need treatment
• You have a sudden, severe loss of blood flow to the leg being treated
• The leg being treated has previously had open surgery to restore blood flow (such as a bypass or artery-cleaning procedure)
• The artery being treated has previously had a stent, laser, or other procedure performed on it
• The main artery feeding into the treated area is completely blocked
• There is evidence of a blood clot in the artery being treated
• The treatment area needs a device other than a standard balloon to open it up
• The narrowed area is near or inside an aneurysm (a bulge in the artery wall)
• There is evidence of blood clot material being dislodged during the procedure
• The blocked area has moderate to severe calcium build-up
• After an initial balloon treatment to open the artery, more than 30% narrowing remains

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