The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Freedom from Target Vessel Instability
研究概览
简要总结
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
详细描述
Patients are eligible to participate in the registry if at least one BXB device is intended to be incorporated (first proximal, connected with aortic main body) to maintain visceral artery perfusion. There are no selection criteria (i.e., inclusion or exclusion criteria) based on main aortic body device used, and to allow better RWD representation of the patient population treated with different aortic component, a cap per main aortic body device has been set
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed Consent Form (ICF) is signed by Subject.
- •Age ≥ 18 years at time of informed consent signature.
- •Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.
- •Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).
- •Patient is willing to adhere to the institutional standard of care follow-up.
排除标准
- •Patient has a prior visceral artery stenting not associated with registry procedure.
- •Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
- •Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.
- •Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- •Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment.
- •Patient has a life expectancy < 1-year.
- •Patient is participating in an investigational study which may confound registry results, unless approved by Gore
研究组 & 干预措施
FEVAR
Patients who are treated with aortic endografts designed exclusively with fenestrations for incorporation of the visceral arteries with at least one BXB device implanted
OTHER
Patients who are treated with other endovascular techniques who required incorporation of BXB as bridging stent (i.e. PMEGs).
BEVAR
Patients who are treated with aortic endografts designed exclusively with directional branches for incorporation of the visceral arteries with at least one BXB device implanted
结局指标
主要结局
Freedom from Target Vessel Instability
时间窗: through 1 year Follow-up
Freedom from any death or rupture related to side branch complication (e.g., endoleaks, rupture); any branch occlusion; or any secondary intervention indicated to treat a branch-related complication, including endoleaks, disconnection, kink, stenosis, occlusion, or rupture
次要结局
- Major Adverse Events(through 5-year follow-up)
- Target Vessel Technical Success(At procedure)
- Procedural Technical Success(at procedure)
- Clinical Success(through 5-year follow-up)
- Freedom from Aneurysm-Related Mortality(through 5-year follow-up)
- Freedom from Target Vessel Instability through 5-year follow-up(through 5-year follow-up)
- Primary Patency(through 5-year follow-up)
- Freedom from Reintervention(through 5-year follow-up)
- Survival(through 5-year follow-up)
- Aneurysm sac changes(through 5-year follow-up)