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

Sponsor
First Affiliated Hospital of Jinan University
Study ID
NCT06752954
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 31, 2024
Start date
Dec 25, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

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

Primary Outcome Measure

Primary patency [ Time Frame: 12-month ]

Central Contacts

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