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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPeking Union Medical College Hospital

About this trial

This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C/D femoropopliteal artery occlusive disease.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • paclitaxel-coated balloon angioplasty or bare mental stents implantation

Treatment groups

200 Participants
are divided into 2 treatment groups