DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
NCT ID: NCT05517291
Last Updated: 2022-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-09-18
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCB
participants in this group will be received drug-coated balloon angioplasty
paclitaxel-coated balloon angioplasty or bare mental stents implantation
paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly
stenting
participants in this group will be received primary selective stenting
paclitaxel-coated balloon angioplasty or bare mental stents implantation
paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly
Interventions
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paclitaxel-coated balloon angioplasty or bare mental stents implantation
paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PASS
Identifier Type: -
Identifier Source: org_study_id
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