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:

• People who are willing and able to give written consent before any study-related procedures take place.
• People who are willing and able to follow the study procedures and attend all follow-up appointments.
• People who have been diagnosed with Critical Limb Ischemia (a serious condition where not enough blood reaches the limbs), classified at a specific severity level known as Rutherford Category 4 or 5 (confirm with trial site).
• People who are at least 18 years old.
• People whose target blockage is located in a specific section of the leg arteries below the knee — either the tibioperoneal trunk, or the upper two-thirds of the anterior tibial, posterior tibial, or peroneal artery.
• People who have only one blockage being treated as part of the trial (other blockages may still be treated using standard hospital care).
• People who have at least one artery below the knee that does not have a significant blockage (less than 50% narrowed).
• People whose target artery measures between 3.0 mm and 3.4 mm in diameter, confirmed using specialised imaging tools.
• People whose target blockage is 18 mm or shorter in length.
• People whose target blockage narrows the artery by 70% or more, as seen on imaging at the time of the procedure.
• People whose target blockage is located at least 2 mm away from any artery branching point, so that placing a stent would not block any branch arteries.
• People in whom the target blockage has been successfully crossed with a guidewire during the procedure.

Who may not be able to join:

• People who are currently taking part in another clinical trial that has not yet reached its main outcome point.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial follow-up period.
• People who have other health conditions, or medical, social, or psychological circumstances that, in the investigator's opinion, could make it difficult to participate or attend follow-up visits.
• People who are legally considered unable to make their own decisions, including those with certain mental health conditions or intellectual disabilities.
• People who have a known allergy or serious reaction to the materials the device is made from (including poly(L-lactide), poly(glycolic acid), lactic acid, and glycolic acid) that cannot be managed with pre-treatment medication, or who have a known reaction to contrast dye used in imaging that cannot be managed with pre-treatment medication.
• People who have a known allergy or serious reaction to aspirin, certain blood-thinning medications (such as clopidogrel, prasugrel, or ticagrelor), or anticoagulant medications (such as heparin or bivalirudin), that would prevent adequate treatment with study medications.
• People who have surgery or another procedure planned within 3 months after the trial procedure that would require stopping blood-thinning medications.
• People whose life expectancy is one year or less.
• People who have had a stroke within the past 3 months and still have a significant level of disability as a result (confirm scoring with trial site).
• People with poor kidney function, specifically an estimated filtration rate below 30 ml/min per 1.73m² (confirm with trial site).
• People with certain abnormal blood count results, including low platelets, low white blood cells, or low haemoglobin levels (confirm specific thresholds with trial site).
• People with a serious immune system condition (such as HIV with a detectable viral load, lupus, or another condition requiring ongoing immune-suppressing treatment). Note: People being treated for HIV with an undetectable viral load, whose immune system is not considered to be compromised, may still be considered eligible (confirm with trial site).
• People with a Body Mass Index (a measure of body weight relative to height) below 18.
• People with a known clotting disorder that increases the risk of arterial blood clots. (Note: people with deep vein thrombosis or conditions that increase that specific risk may still be considered eligible — confirm with trial site.)
• People who need clot-dissolving treatment (thrombolysis) as the main treatment for their limb condition, or who require other treatment for sudden limb ischemia.
• People who have previously had, or currently require, surgical bypass or revascularisation involving any artery in the same leg as the target blockage.
• People who show signs of serious limb infection or blood infection (septicaemia) at the time of assessment, including high fever, elevated white blood cell count, or low blood pressure (confirm specific thresholds with trial site).
• People with extensive tissue loss in the foot that would require complex reconstruction or a non-standard amputation to address.
• People who have multiple blockages close together at the target site, with less than 2 cm of clear vessel between them.
• People in whom balloon dilation of the target blockage during the procedure did not reduce the narrowing to below 50%.
• People who have previously had a metal stent placed in the target artery.
• People who had an unsuccessful balloon dilation of the target blockage within the 60 days before the procedure.
• People whose target artery has another significant blockage (50% or more narrowed) elsewhere along the vessel.
• People who have a significant blockage (50% or more) in an artery further down the leg that the target vessel supplies blood to, and that also needs to be treated at the same time.
• People who show evidence of blood clots or clot-related debris in the arteries of the same leg on imaging.
• People who have an untreated or unsuccessfully treated significant blockage in an artery further up the leg that is reducing blood flow to the target area.
• People who have an aneurysm (abnormal bulging of an artery wall) in the iliac, common femoral, superficial femoral, popliteal, or target artery of the same leg.
• People whose target blockage has a high likelihood of requiring a specialised plaque-removal procedure (atherectomy) at the time of the trial procedure.

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