Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 259
- 试验地点
- 14
- 主要终点
- Number of Participants With Target Vessel Patency
研究概览
简要总结
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
详细描述
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
The registry procedures consist of two phases, retrospective phase and prospective phase.
The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature).
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017
- •Age ≥18 years at the time of implant
- •Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations.
排除标准
- •Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure
- •Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
- •Patient treated using physician-modified endovascular grafts
- •Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan
- •At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment
- •Patient was pregnant at the time of treatment.
- •Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints.
- •Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.
结局指标
主要结局
Number of Participants With Target Vessel Patency
时间窗: 12 months
Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.
次要结局
未报告次要终点