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Not yet recruiting NCT06124755

The Efficacy of Heparin-boned Viabahn Endoprosthesis and Paclitaxel-coated Balloons for Complex Femoropopliteal Lesions

No phase Interventional Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Viabahn endoprosthesis group, Drug-coated balloon group.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparing the Efficacy of Heparin-boned Viabahn@ Endoprosthesis and Paclitaxel-coated Balloons for Endovascular Treatment of Complex Femoropopliteal Lesions

Overview

The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.

Detailed description

This is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. Approximately 60 subjects will be enrolled and randomized into a Viabahn preferred group (study arm) or drug-coated balloons (DCB) group (control arm); Each group will include 30 patients. All enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.

Interventions

  • Device Viabahn endoprosthesis group
    Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis.
  • Device Drug-coated balloon group
    Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon.

Primary outcome measures

  • Primary patency [Time frame: 24-month]
  • Freedom from a composite of Major adverse events (MAEs) [Time frame: 24-month]
Secondary outcome measures (7)
  • Procedural success [Time frame: Immediately after interventional surgery]
  • Primary assisted patency [Time frame: 24-month]
  • Secondary patency [Time frame: 24-month]
  • Clinically-driven target vessel revascularization (CD-TVR) [Time frame: 24-month]
  • Primary sustained clinical improvement [Time frame: 24-month]
  • Secondary sustained clinical improvement [Time frame: 24-month]
  • Vasc quality of life score [Time frame: 24-month]

Eligibility criteria

Inclusion criteria

  • The patient presented a score from 2 to 5 following Rutherford classification.
  • The patient is willing to comply with specified follow-up evaluations at the specified times.
  • The patient is ≥ 18 years old.
  • Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
  • The patient has a projected life expectancy of at least 24 months
  • Before enrolment, the guidewire has crossed the target lesion
  • Subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (CTO) length ≥15cm.
  • There is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot.
  • Origin and proximal 1 cm of Superficial Femoral Artery (SFA) are patent.
  • Reference vessel diameter (RVD) ≥ 4 mm by visual estimation.

Exclusion criteria

  • Previous bypass surgery or stenting in the target vessel
  • Patients who exhibit acute intraluminal thrombus at the target lesion vessel
  • Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
  • Pregnant women or Female patients with potential childbearing
  • Use of thrombectomy, atherectomy, or laser devices during the procedure
  • Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
  • The patient is currently participating in another investigational drug or device study that interferes with the study
  • Significant renal dysfunction (Serum creatinine >3.0mg/dl)
  • Patient with Known allergy to contrast media
  • Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
  • Femoral or popliteal aneurysm.
  • Current peritoneal or hemodialysis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Identifiers

NCT: NCT06124755 · The Virtue study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗