Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from the 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 signed and dated a consent form agreeing to take part.
• You are between 18 and 85 years old (inclusive).
• You have been assessed as having severe leg pain when walking or wounds/sores on your leg due to poor blood flow (confirm with trial site for exact classification).
• Imaging taken at the time of the procedure confirms a complete blockage in a leg artery below a certain point, either above or below the knee, that has not been treated before.
• The total length of all blockages combined is less than 40 cm.
• The blockage is confirmed as 100% closed by imaging at the time of the procedure.
• If the blockage is below the knee, at least one blood vessel in that leg must still be open enough to carry blood flow (less than 50% blocked), confirmed by imaging.

Who may not be able to join:

• Your life expectancy is less than 12 months.
• You are pregnant or breastfeeding.
• You have had a heart attack or stroke in the last two months.
• You have unstable heart disease or another serious uncontrolled health condition.
• You have a known bleeding or blood-clotting disorder.
• You have a known allergy to nickel, titanium, or their alloys (metals used in some medical devices).
• You have signs of an active infection anywhere in your body, including in the affected leg.
• You are currently using cocaine or other substances of abuse.
• You have received clot-dissolving (thrombolytic) treatment in the last two weeks.
• You have a known severe allergy to contrast dye or medications used during or after the procedure.
• You are already taking part in another study involving an investigational drug or device.
• You have surgery or another vascular procedure planned within 30 days of this procedure.
• You have previously had a bypass surgery involving the target blood vessel.
• The blocked vessel being treated has already been treated before with a balloon or stent, including a failed attempt during this same procedure.
• You have tested positive for COVID-19, following the trial site's standard testing process.
• Your kidney function is significantly reduced (low eGFR or high creatinine levels — confirm specific values with trial site).
• Your platelet count (cells that help blood clot) is very low (confirm specific value with trial site).
• If the blockage is below the knee, there is no sufficiently open vessel remaining to carry blood flow in that leg.
• There is a fresh or recent blood clot inside the target blood vessel.
• There is an abnormal bulge (aneurysm) in a nearby blood vessel that is at least twice the normal vessel size.
• There is already damage such as a tear or puncture in the blood vessel before the procedure begins that requires urgent treatment.

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