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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viabahn endoprosthesis group | Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by Viabahn endoprosthesis. |
| |
| Drug-coated balloon group | Patients underwent endovascular treatment for femoropopliteal lesions. The lesion will be treated by drug-coated balloon. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viabahn endoprosthesis group | Device | Viabahn endoprosthesis group: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. | 12-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 | 12-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 | |
|---|---|---|---|---|
| Jiandong Guo | Contact | +8613420187264 | 407939203@qq.com |
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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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| 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.
| 12-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. | 12-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. | 12-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. | 12-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. | 12-month |
| Vasc quality of life score | Change of Vasc quality of life score | 12-month |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |