Comparing two treatments for femoropopliteal artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Leng Ni, MD
• Email: nileng@163.com
• Phone: 86-1069152501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.