Drug-Eluting Balloons vs Mimetic Stents for Popliteal Artery Disease

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for a condition called popliteal artery disease, which can cause pain and limit mobility in people with severe circulation problems in their legs. The trial compares the use of special stents made of nitinol, a flexible metal, to drug-eluting balloons that release medication to help open up the artery. Researchers are trying to find out which method is more effective in improving blood flow for patients experiencing critical lower limb ischemia, a serious form of reduced blood supply to the legs.

To participate in the trial, individuals need to be between the ages of 65 and 75 and have been diagnosed with critical lower limb ischemia affecting the popliteal artery, which is located behind the knee. They must be admitted to the Vascular Surgery Department at Bellvitge Hospital and provide their consent to join the study. Participants can expect to receive one of the two treatments and will be closely monitored for their progress. It's important to note that those who have had prior surgeries on the same limb or have certain other medical conditions may not be eligible for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients diagnosed of critical lower limb ischemia according to the TASC (TransAtlantic Inter-Society Consensus) working group.
• • 2. Patients admitted to the Vascular Surgery Department of the Bellvitge Hospital University to treat critical lower limb ischemia for endovascular treatment.
• • 3. With involvement of the Popliteal artery in-between the Hunter's canal and the start of the tibial artery branch.
• • 4. WOCBP must use highly effective methods of contraception.
• • 5. Patients who sign the written informed consent.
• Exclusion Criteria:
• • 1. Patients diagnosed of critical lower limb ischemia according to the TASC working group undergoing medical treatment or open surgery.
• • 2. Patients requiring amputation.
• • 3. Patients who underwent previous revascularization of the same limb (same artery).
• • 4. The main involvement is from an arterial territory other than the popliteal artery.
• • 5. Pregnant women.
• • 6. Inability of overcoming the arterial lesion during the endovascular procedure.
• • 7. Affected artery's diameter \<4 mm.