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| Name | Class |
|---|---|
| Chengdu University of Traditional Chinese Medicine | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viabahn endoprosthesis group | Experimental | Femoropopliteal lesions treated with Viabahn endoprosthesis. |
|
| Drug-coated balloon group | Active Comparator | Femoropopliteal lesions treated with drug-coated balloon endoprosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viabahn endoprosthesis group | Device | Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | Peak systolic velocity ratio (PSVR ≤2.4) without any repeat intervention. | 24-month |
| Freedom from a composite of Major adverse events (MAEs) | Freedom from MAEs is defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major amputation, and all-cause of death | 24-month |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Procedural success is defined as technical or device success without major adverse events during the hospital stay. | Immediately after interventional surgery |
| Primary assisted patency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qihong Ni, M.D. | Contact | +8615801900772 | niqihong1989@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Xuanwu Hospital, Beijing |
| OTHER |
| Qingdao Haici Hospital | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Fudan University | OTHER |
| Huashan Hospital | OTHER |
| Xiamen Cardiovascular Hospital, Xiamen University | OTHER |
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| Drug-coated balloon group | Device | Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon. |
|
Primary assisted patency is defined as maintaining patency in the target vessel after a repeat intervention to regain patency prior to complete occlusion.
| 24-month |
| Secondary patency | Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment. | 24-month |
| Clinically-driven target vessel revascularization (CD-TVR) | clinically-driven target vessel revascularization (CD-TVR) is defined as repeat intervention performed during enrollment in the clinical study. | 24-month |
| Primary sustained clinical improvement | Defined as a sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients. | 24-month |
| Secondary sustained clinical improvement | Defined as a sustained upward shift of at least one category on the Rutherford classification3, including the need for repeated target lesion revascularization (TLR) in surviving patients. | 24-month |
| Vasc quality of life score | Change of Vasc quality of life score | 24-month |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |