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Official title DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease
ClinicalTrials.gov ID: NCT05517291
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.