Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 85
- 主要终点
- Deployment Technical Success
研究概览
简要总结
A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.
详细描述
The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.
Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
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
- •Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
- •Patient has been or is intended to be treated with an eligible registry device
- •Patient is age ≥ 18 years at time of informed consent signature.
排除标准
- •Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
- •Patient with exclusion criteria required by local law.
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
研究组 & 干预措施
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device)
Patients treated with the EXCC Device
GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device)
Patients treated with the IBE Device
结局指标
主要结局
Deployment Technical Success
时间窗: Time of Surgery
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.
Lesion Rupture
时间窗: Time of Surgery through Year 10
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or Computed Tomographic Angiography (CTA) scan
Lesion Enlargement
时间窗: Time of Surgery through Year 10
An increase in maximum vessel (e.g., aorta or treated branch) diameter of \> 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CTA scans
Device Migration
时间窗: Time of Surgery through Year 10
Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.
Loss of aortic / branch patency
时间窗: Time of Surgery through Year 10
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Endoleaks
时间窗: Time of Surgery through Year 10
Perfusion of a treated lesion identified through imaging analysis
New onset renal failure
时间窗: Time of Surgery through Day 30
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks
Device integrity events
时间窗: Time of Surgery through Year 10
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis
Lesion-related Mortality
时间窗: Day 30 through Year 10
Death related to the index endovascular procedure, secondary procedure associated with the index lesion or the registry device, or any death where the treated disease / index lesion or registry device caused or significantly contributed to the death
Renal function deterioration
时间窗: Time of Surgery through Year 10
New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
Reintervention
时间窗: Time of Surgery through Year 10
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure.
次要结局
- New onset buttock claudication / erectile dysfunction(Time of Surgery through Year 1)
- Characterization of remote data collection to supplement follow-up activities(Time of Surgery through Year 10)