DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for a condition called TASC C/D femoropopliteal artery disease, which affects blood flow in the legs. The study looks at the effectiveness and safety of using a special balloon coated with a medication (called a paclitaxel-coated balloon) versus placing a stent, which is a tiny tube that helps keep the artery open. Researchers want to see how well each method works over time for patients suffering from this condition.

To participate in this trial, you need to be between 18 and 85 years old and have specific types of artery blockages in your leg that meet certain criteria. Participants should also be able to attend follow-up appointments and complete required tests. If you join, you'll receive one of the two treatments and be monitored to see how well it helps your condition. It's important to know that there are some exclusions, such as having certain other health issues or recent treatments, so not everyone will qualify. If you're interested, discussing this with your doctor could be a great next step!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject age 18-85yrs.
• • Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
• • Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
• • Rutherford category 2-5.
• • Subject has a de novo TASC C/D femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.
• • The total length of target lesion ≤30cm.
• • Reference vessel diameter \>4 mm and \<6.5 mm by visual assessment.
• • Patent inflow artery with stenosis \<30% and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis).
• • A guidewire has successfully traversed the target treatment segment.
• Exclusion Criteria:
• • Acute thrombus in the target vessels.
• • Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.
• • Subject received prior stents implantation with in-stent restenosis or occlusion.
• • Reintervention of the target lesion \<90 days before the study procedure.
• • Acquired thrombophilia or uncontrolled hypercoagulation states.
• • Life expectancy \<12 months.
• • Severe renal（SCr≥2.5 mg/dl）or hemodialysis dependence.
• • Pregnancy, suspected pregnancy, or breastfeeding during study period.
• • Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).
• • Hypersensitivity to nitinol and/or paclitaxel.