Individual Patient Data Analysis of Viabahn for Peripheral Arterial Disease

Study Overview
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Brief Summary
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To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.

Detailed Description
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Rationale: Studies on the efficacy of self-expanding covered stents for the treatment of patients with superficial femoral artery (SFA) occlusive disease have mainly focused on stent patency. Subgroup analysis was often not feasible, related to small sample sizes. This pooled analysis of individual patient-level data provides larger sample sizes and a more heterogeneous population, which allows for the ability to perform subgroup analyses to identify patients that will most benefit from VSX treatment. The current analysis will provide insights into the effectiveness of the VSX device for specific subgroups. Objective: To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes. Study design: Multicenter retrospective individual patient data meta-analysis. Study population: Patients treated with a VSX device for de novo or restenotic lesions of the superficial femoral artery and previously enrolled in a prospective VSX study whom were treated for SFA disease with the latest generation heparin-bonded Viabahn, and published in peer reviewed journals. Main study parameters/endpoints: The primary study parameter is primary patency at 12-months. In addition, for all subjects and for subgroups as described further below, the following secondary endpoints will be evaluated through follow-up: primary patency at 24 months, primary assisted patency, secondary patency, freedom from Target Lesion Revascularization (TLR) at 12 and 24 months, clinical Improvement, minor and major amputation, mortality. The following subgroup analysis will be performed if sufficient data are available: critical limb threatening ischemia patients (Rutherford 4-6), patients with intermittent claudication (Rutherford 1-3), chronic total occlusions, by gender, by number of runoff vessels, lesion length, TASC II lesion classification, calcified lesions, by device diameter.

Official Title
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Individual Patient Data Meta-Analysis of Prospective Studies of Patients Treated With the GORE® VIABAHN® Endoprosthesis With Heparin Bioactive Surface (VSX) for Peripheral Arterial Disease (INSIGHT VSX)

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: Viabahn implanted


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient was enrolled and treated with the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface device in a Gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery. Lesions ≥10 cm in length and TASC C or D classification will be included Patient-level data can be obtained and pooled with other studies Exclusion Criteria: Patient was not formally enrolled in their corresponding study (e.g., training cases) Patient was enrolled for treatment of in-stent restenotic lesions. Patient has incomplete or missing data that does not allow for analysis. Case reports (n<10 patients)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Viabahn implanted|An individual patient data analysis obtained from databases used in prospective studies that published results of patients treated with the latest generation heparin-bonded Viabahn in the femoropopliteal artery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Primary patency is defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR < 2.5) or no angiographic evidence of stenosis > 50% if CDUS is uninterpretable or unavailable. | at 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | Primary patency is defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-coded duplex sonography (CDUS, PSVR < 2.5) or no angiographic evidence of stenosis > 50% if CDUS is uninterpretable or unavailable. | at 24 months | 
| Primary assisted patency | Primary assisted patency is defined as flow through the treated lesion with or without repeat percutaneous intervention completed prior to complete vessel occlusion. | 12 and 24 months | 
| Secondary patency | Secondary patency is defined as patency in the target lesion maintained by repeat intervention after complete occlusion of the treated arterial segment. | 12 and 24 months | 
| Freedom from Target Lesion Revascularization (TLR) | Freedom from revascularization of the treated lesion after either restenosis or occlusion by means of a percutaneous vascular intervention, surgical by-pass, thrombolysis, or other such invasive means. | 12 and 24 months | 
| Clinical Improvement | Clinical improvement is defined as at least one-group improvement in Rutherford Classification compared to baseline. | 12 and 24 months | 
| Major amputation | Surgical removal of a portion of the study limb (generally above the ankle, transmetatarsal, or metatarsal) | 12 and 24 months | 
| Mortality | Death, overall and procedure-related (until 30 days) | 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral artarial disease, endovascular treatment, endoprosthesis, Viabahn, Individual patient data analysis