Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 34
- 主要终点
- Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
研究概览
简要总结
The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).
详细描述
A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
- •Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
- •Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
- •Age ≥18 years at the time of CERAB procedure.
- •Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
排除标准
- •Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
- •Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
- •Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
研究组 & 干预措施
GORE VIABAHN® VBX Balloon Expandable Endoprosthesis
Patient was implanted with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
干预措施: GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) (Device)
结局指标
主要结局
Primary Effectiveness Endpoint: 1-Year Primary patency (hypothesis testing)
时间窗: 1-Year
Proportion of patients maintaining primary patency at 1 Year
Primary Safety Endpoint: 30-day Morbidity (hypothesis testing)
时间窗: 30-Day
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
次要结局
- Technical Success(At index procedure)
- Mortality(30-Day)
- Device Integrity(1 year)
- Primary assisted patency(1 year)
- Secondary patency(1 year)
- Freedom from Target Lesion Revascularization(1 year)
- Survival(1 Year)
- Freedom from Clinically-Driven Target Lesion Revascularization(1 year)