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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 977
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
To evaluate the effectiveness of the VSX device in pre-determined patient populations to understand the patient characteristics that impact outcomes.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Primary patency
时间窗: at 12 months.
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.
次要结局
- Secondary patency(12 and 24 months)
- Major amputation(12 and 24 months)
- Primary patency(at 24 months)
- Primary assisted patency(12 and 24 months)
- Freedom from Target Lesion Revascularization (TLR)(12 and 24 months)
- Clinical Improvement(12 and 24 months)
- Mortality(12 and 24 months)