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Not yet recruiting NCT06752954

The Effectiveness of Covered Stent Viabahn and Drug-coated Balloon for Complex Femoropopliteal Artery Lesions

— Observational 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of the Effectiveness of Viabahn® Vs. Drug-Coated Balloon With/without Bail-Out Bare Metal Stent in Treating Complicated Femoropopliteal Lesions

Overview

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

Detailed description

This is a multicenter, observational prospective cohort clinical trial with clinical and image follow-up for two years post-procedure. Approximately 200 subjects will be enrolled into a Viabahn group (observe arm) or drug-coated balloons (DCB) group (contrast arm); Each group will include 100 patients.

All enrolled patients will be followed up for 12 and 24 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, 3,6 and 9 months.

Interventions

  • Device Viabahn endoprosthesis group
    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: 12-month]
  • Freedom from a composite of Major adverse events (MAEs) [Time frame: 12-month]
Secondary outcome measures (7)
  • Procedural success [Time frame: Immediately after interventional surgery]
  • Primary assisted patency [Time frame: 12-month]
  • Secondary patency [Time frame: 12-month]
  • Clinically-driven target vessel revascularization (CD-TVR) [Time frame: 12-month]
  • Primary sustained clinical improvement [Time frame: 12-month]
  • Secondary sustained clinical improvement [Time frame: 12-month]
  • Vasc quality of life score [Time frame: 12-month]

Eligibility criteria

Inclusion criteria

  • 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 is willing to comply with specified follow-up evaluations at the specified times.
  • The patient presented a score from 2 to 5 following Rutherford classification.
  • The patient has a projected life expectancy of at least 24 months
  • 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.

Exclusion criteria

  • Patients with known hypersensitivity or contraindication to any of the following medications: Contrast media, Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
  • Pregnant women or Female patients with potential childbearing
  • Patients who exhibit acute intraluminal thrombus at the target lesion vessel
  • Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
  • The patient is currently participating in another investigational drug or device study that interferes with the study

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

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06752954 · The support study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗