Comparing two treatments for femoropopliteal artery disease

Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C/D Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial

This study tests whether a special balloon treatment or a stent works better for people with blocked arteries in their legs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05517291 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness and safety of paclitaxel-coated balloon angioplasty versus primary selective stenting in patients with TASC C/D femoropopliteal artery occlusive disease. Participants aged 18-85 with specific artery conditions will be enrolled and monitored for mid- and long-term outcomes. The study aims to determine which treatment provides better results for patients suffering from this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with specific artery lesions that meet the study's inclusion criteria.

Not a fit: Patients with acute thrombus in the target vessels or those with prior stent implantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with femoropopliteal artery disease.

How similar studies have performed: Other studies have explored similar interventions, but the specific comparison of these two treatments in this context is novel.

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.

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Leng Ni, MD

Conditions Safety Issues; Efficacy, Self