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 are 18 years of age or older
• Your doctor has recommended a procedure to remove plaque buildup from a blood vessel in your lower leg or foot (called atherectomy)
• Your doctor believes you are expected to live for more than 1 year
• Tests show that blood flow to your lower leg or foot is significantly reduced (measured by a blood pressure comparison test at the ankle or toe)
• Your leg symptoms fall within a specific range of severity — from moderate leg pain at rest to minor tissue loss or ulcers (confirm with trial site)
• Your doctor believes you are a suitable candidate for a minimally invasive procedure to open the blocked blood vessel
• You are willing and able to follow all the steps and check-ups required by the study
• You have read and signed a consent form agreeing to take part
• The blocked area in your blood vessel is at least 70% narrowed, as seen on imaging
• The total length of the area to be treated is no more than 20 cm (about 8 inches)
• The blood vessel being treated is within a specific size range as seen on imaging
• At least one blood vessel below the knee remains reasonably open and is supplying blood to the foot

Who may not be able to join:

• You have an active infection in the leg being treated
• You have had a procedure or surgery on the leg being treated within the last 30 days
• You have another surgical or medical procedure planned within 30 days after this study procedure
• The other leg also needs a procedure done at the same time or within the next 30 days
• Your leg condition is at the most severe stage, involving significant tissue death (Rutherford category 6)
• You have significant kidney disease or are on dialysis
• You have recently had a heart attack, stroke, or another serious uncontrolled health condition
• You have had a heart attack or stroke within the past two months
• You are pregnant or breastfeeding
• You are already taking part in another clinical trial that could interfere with this one
• You cannot take blood-thinning or clot-preventing medications for any reason
• You have a bleeding disorder, a very low platelet count, or problems with blood clotting
• You have a known allergy to the dye used in imaging or to medications used in the procedure that cannot be managed with other treatments
• You have a history of a serious reaction to a blood-thinning medication called heparin
• You have received clot-dissolving (thrombolytic) treatment within the past two weeks
• The blocked area in your blood vessel is inside an existing graft or artificial vessel
• There is a significant blockage further up the blood vessel that was not successfully treated before this procedure
• You have a history of bleeding in the brain or stomach, or a known brain aneurysm
• You belong to a group considered vulnerable, such as people who are incarcerated or have significant cognitive difficulties
• You have certain serious foot complications, including bone infection spreading to the foot bones, gangrene in specific areas of the foot, certain types of large or deep foot ulcers, heel wounds, wounds involving the heel bone, wounds that are caused by nerve damage rather than poor blood flow, or wounds needing major reconstructive surgery (confirm with trial site for details)
• You have moderate to severe heart failure that significantly limits your daily activities
• More than 2 separate blockages need to be treated with the study device
• A complication occurred from another device used before the study device was introduced
• The blockage is inside a previously placed stent (a small metal tube used to keep vessels open)
• There is a significant tear in the blood vessel wall that is affecting blood flow
• There is evidence that small clots or debris have already broken off and moved further down the blood vessel
• A guidewire cannot be passed through the blockage within the vessel's main channel during the procedure

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