Ongoing Clinical Trials for Peripheral Arterial Occlusive Disease
There are currently 3 ongoing clinical trials investigating new treatments for peripheral arterial occlusive disease, focusing on preventing kidney complications during vascular procedures, testing novel blood-thinning medications, and evaluating cell therapy for patients with chronic limb-threatening ischemia. These studies are being conducted in Austria, Finland, and Germany.
Clinical trial locations
- Austria
- Finland
- Germany
Study on Preventing Kidney Problems in Peripheral Arterial Disease Patients Using Carbon Dioxide and Iopamidol, Iomeprol, and Iopromide During Vascular Procedures
This trial is investigating a new approach to reduce kidney damage during procedures to open blocked arteries in the legs. It compares the use of carbon dioxide gas with traditional iodine-based contrast dyes during vascular imaging and treatment.
Main inclusion criteria: Patients must have symptomatic peripheral arterial disease requiring a procedure on arteries below the groin. They need to be at increased risk of kidney injury, with a risk score of 5 or more points and kidney function test results showing an eGFR of less than 60. Participants must be at least 18 years old and able to provide written informed consent. Both carbon dioxide and traditional contrast imaging methods must be feasible according to the treating physician’s judgment.
Main exclusion criteria: The study excludes patients with a history of severe allergic reactions to contrast media, severe kidney disease, kidney transplant recipients, and those with severe heart failure. Pregnant or breastfeeding women, patients currently in another clinical trial, and those with uncontrolled high blood pressure, severe liver disease, active infections, or blood clotting disorders cannot participate.
Study focus: The trial aims to determine whether using carbon dioxide injection instead of traditional iodinated contrast during peripheral vascular interventions can reduce the occurrence of major adverse kidney events. Patients will be monitored for up to 90 days after their procedure to assess kidney function and detect any complications.
Investigational approach: The study uses automated carbon dioxide injection as an alternative to traditional contrast dyes containing substances like iopamidol, iomeprol, iopromide, iodixanol, iohexol, and ioversol. The goal is to minimize kidney damage while maintaining the quality of imaging needed for the procedure.
Study of APAC (antiplatelet, anticoagulant) treatment in patients with peripheral arterial disease and chronic limb-threatening ischemia during blood vessel restoration procedure
This trial is testing a new medication called APAC that combines blood-thinning and anti-clotting properties in patients with severe blood flow problems in their legs. The study evaluates the safety and effectiveness of this treatment when given during procedures to restore blood flow.
Main inclusion criteria: Men aged 45-85 years and postmenopausal women up to 85 years old can participate. Patients must have severe leg artery disease with an ankle-brachial index less than 0.7 and recent blood vessel imaging from the past 3 months. They need to be taking blood-thinning medication for at least 5 days before treatment, be on appropriate cholesterol-lowering medication, and be able to perform a walking test on a treadmill. Male participants must agree to use condoms and not donate sperm during the study.
Main exclusion criteria: The study excludes patients with a history of severe allergic reactions, active or recent major bleeding within the past 3 months, significant kidney or liver problems, and blood clotting disorders. Patients with active cancer, recent heart attack or stroke within 6 months, uncontrolled high blood pressure, pregnancy or breastfeeding, recent participation in another trial, history of substance abuse, acute infections, certain mental health conditions, or life expectancy less than 6 months cannot join.
Study focus: The trial evaluates the safety and tolerability of APAC when administered to patients undergoing blood vessel restoration procedures. It monitors bleeding events, walking ability, blood flow in the legs, quality of life, and overall health outcomes over a 90-day period. The study includes different dosing approaches, with some patients receiving single doses and others receiving weekly doses.
Investigational drug: APAC is a heparin proteoglycan mimetic medication that works as both an antiplatelet and anticoagulant agent. It is administered through intravenous and intra-arterial routes during endovascular procedures to help prevent blood clots and improve blood flow to affected limbs.
Study on the Effects of TRI-001 for Patients with Chronic Limb Threatening Ischemia Due to Peripheral Arterial Disease
This trial is investigating TRI-001, a cell therapy treatment involving allogeneic regulatory macrophages, for patients with chronic limb-threatening ischemia. The study aims to determine if this innovative treatment can help heal wounds and improve blood flow in severely affected limbs.
Main inclusion criteria: Patients must be adults not older than 85 years with objective evidence of chronic limb-threatening ischemia due to peripheral arterial disease. They need to have minor tissue loss without tendon or bone exposure, with at least one persistent, non-healing wound present for at least 2 weeks and measuring 3 cm² or more. The affected leg must meet specific blood flow criteria confirmed in two exams at least one week apart, have sufficient blood flow in certain arteries, and have no promising conventional treatment options or be ineligible for revascularization. Patients need adequate kidney, liver, and bone marrow function, must be taking anti-platelet medication unless contraindicated, and must agree to use effective birth control.
Main exclusion criteria: The study excludes patients who do not have chronic limb-threatening ischemia due to peripheral arterial disease, those outside the specified age range, and members of vulnerable populations.
Study focus: The trial evaluates both the safety and effectiveness of TRI-001 over a 12-month period. The primary focus is on the safety profile and the percentage change in wound size. Secondary outcomes include time to complete wound healing, changes in pain levels, and quality of life assessments. Participants receive a single injection of either TRI-001 or placebo directly into the muscle and attend regular follow-up visits for monitoring.
Investigational treatment: TRI-001 is administered as a single intramuscular injection containing allogeneic regulatory macrophages. This experimental cell therapy aims to improve blood flow and promote healing in limbs affected by chronic limb-threatening ischemia by targeting specific pathways at the molecular level.
Summary
The three ongoing clinical trials for peripheral arterial occlusive disease represent diverse therapeutic approaches to addressing this condition and its complications. Two trials are being conducted in Germany, with one also extending to Austria and another trial taking place in Finland. The studies focus on three distinct treatment strategies: preventing kidney damage during vascular procedures using carbon dioxide, testing a novel dual-action blood-thinning medication during blood vessel restoration, and evaluating cell therapy for severe cases with chronic limb-threatening ischemia.
Each trial addresses different aspects of disease management. The carbon dioxide study targets procedural safety by reducing kidney complications, the APAC trial investigates improved blood-thinning therapy during interventions, and the TRI-001 study explores regenerative medicine approaches for patients with limited conventional treatment options. Together, these trials reflect the ongoing efforts to improve outcomes for patients with peripheral arterial disease through prevention of complications, optimization of procedural treatments, and development of innovative therapies for advanced disease stages.
