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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
paclitaxel-coated balloon angioplasty or bare mental stents implantation
Devicepaticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: DCBExperimental treatment 1 intervention
Group B: stentingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
1-year primary patency rate
Time frame
1 yearSecondary outcomes
1
clinical-driven target lesion revascularization
Time frame
1, 2 and 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov