Phase 3 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 read, understood, and signed a consent form, and are willing to attend all study visits and follow all study procedures for the full duration of the trial.
• People who are 18 years of age or older.
• Women who could become pregnant must agree to use a highly effective form of contraception (or abstinence) for at least 90 days after receiving the study treatment.
• People who have severe leg pain when walking (classified as Rutherford category 3) or more serious reduced blood flow to the leg that threatens the limb (classified as Rutherford categories 4–5).
• People who have up to two blockages or narrowings in specific leg arteries below (or spanning) the knee joint that meet certain size, location, and length requirements as assessed by the treating doctor during the procedure (confirm with trial site for full technical details).
• People whose procedure is successful, meaning the treated artery has less than 30% blockage remaining, good blood flow to the foot, and no serious complications, as judged by the treating doctor.

Who may not be able to join:

• People who are currently enrolled in another clinical study involving a vascular drug or device that has not yet reached its main study goal, or who have previously participated in this same trial.
• People who are pregnant, breastfeeding, or planning to become pregnant in the first 12 months after joining the study.
• People who have another medical, social, or psychological condition that the investigator believes would prevent them from completing the study or attending follow-up visits.
• People who are legally incapacitated or lack the legal authority to make their own decisions.
• People who are not expected to survive more than one year.
• People who have received, are currently receiving, or are planned to receive immune-suppressing drugs, immunotherapy, or chemotherapy within two months before or after the study procedure.
• People whose blood platelet count or haemoglobin level falls outside certain acceptable ranges (confirm with trial site for specific values).
• People who cannot receive certain medications used in this trial — including a specific antihistamine, the drug temsirolimus, or contrast dye used in imaging — due to known allergies or medical contraindications (note: some contrast dye allergies may be managed with prior treatment, confirm with trial site).
• People who have a tumour in the brain or central nervous system.
• People who have had a heart attack within the 30 days before the study procedure.
• People who have had a stroke within the 90 days before the study procedure.
• People who have had bleeding in the brain within the one year before the study procedure.
• People who have had a vascular surgery or procedure within 30 days before the study procedure, or have one planned within 30 days after (some exceptions apply — confirm with trial site).
• People who have a previously placed bypass graft that is still working and sits within 3 cm of the target blockage.
• People who are completely bedridden and unable to move at all (those who use a wheelchair but can move independently may still be eligible — confirm with trial site).
• People who are planned to have a major amputation above the ankle in the affected leg.
• People who have already had an amputation of the affected leg above the toe or front of the foot, or who had a major amputation of the other leg less than one year ago and cannot walk independently.
• People who show signs of serious limb infection or blood infection (such as high fever, very high white blood cell count, or low blood pressure) at the time of assessment — though some manageable foot infections treated with antibiotics may be acceptable (confirm with trial site).
• People who have extensive tissue damage in the foot that would require complex reconstruction or an amputation higher up the foot than a standard type (confirm with trial site for specific wound types).
• People whose liver test results are more than 1.5 times the upper limit of the normal range.
• People whose kidneys are functioning at a very low level (eGFR below 30), unless they are already on stable, long-term dialysis.
• People whose arterial disease in the affected leg is so advanced that the treating doctor does not believe a successful outcome is likely.
• People who have untreated significant narrowings or complications in the blood vessels leading to or from the target blockage, with more than 30% blockage remaining after treatment.
• People who have received radiation therapy, a specific type of internal radiation, cryotherapy, or a drug-coated balloon treatment in the target area within the previous 6 months, or as part of the current procedure.
• People who have had a permanent (non-dissolving) stent placed in the target blockage area previously, or a dissolving stent placed there within the past 12 months.
• People who develop a severe tear in the artery wall within the target area after the opening procedure but before the study drug is delivered.
• People who have an untreated bulge (aneurysm) in certain major arteries of the affected leg.
• People who have a visible blood clot in the target area that requires clot-removal treatment.
• People who show evidence of clot or debris travelling to smaller vessels in the affected leg during the procedure.
• People whose guide wire cannot be passed through the target blockage during the procedure (though a specific alternative wire technique is allowed — confirm with trial site).
• People who have very heavy calcium build-up in the target blockage that, in the doctor's judgement, would prevent the study device needle from passing through the vessel wall.

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