Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 155
- 试验地点
- 19
- 主要终点
- Lesion Rupture (treated area)
研究概览
简要总结
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.
详细描述
The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, 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® TAG® Thoracic Branch Endoprosthesis
Patients treated with the TBE Device
干预措施: GORE® TAG® Thoracic Branch Endoprosthesis (Device)
结局指标
主要结局
Lesion Rupture (treated area)
时间窗: Time of Surgery through Year 2
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
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. The absence of any additional corrective procedure related to the device, procedure, or withdrawal of the delivery system. Events will not include interventions at the access site(s), lumbar drains to address spinal cord ischemia, or additional interventions to address non-treatment areas.
Device Integrity Events
时间窗: Time of Surgery through Year 2
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis.
Endoleaks (Type I-V)
时间窗: Time of Surgery through Year 2
Perfusion of a treated lesion identified through imaging analysis.
Device Migration
时间窗: Time of Surgery through Year 2
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.
Paraparesis
时间窗: Time of surgery through Day 30
New onset spinal cord injury causing a minor motor deficit of the lower extremities.
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.
Reintervention
时间窗: Time of Surgery through Year 2
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure. This may include surgical or interventional treatment for endoleaks, access site(s) complications, disease progression (including interventions to address issues related to non-treated area of the index lesion, such as bare stent implantation to address bowel ischemia associated with aortic dissection), spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery.
Lesion-related Mortality
时间窗: Day 30 through Year 2
Death related to the index endovascular procedure or following conversion to open repair and death related to a complication from a secondary procedure associated with the index lesion or registry device. Any death where the treated disease / index lesion or registry device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.
Loss of Aortic / Branch Patency
时间窗: Time of Surgery through Year 2
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Stroke
时间窗: Time of Surgery through Year 2
Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that either persists for \> 24 hours or until death or symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction.
Renal Function Deterioration
时间窗: Time of surgery through Year 2
New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
Lesion Enlargement (treated area)
时间窗: Time of Surgery through Year 2
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 CT / CTA scans.
Paraplegia
时间窗: Time of surgery through Day 30
New onset spinal cord injury rendering a subject non-ambulatory.
次要结局
- Transient Ischemic Attack (TIA)(Time of Surgery through Year 2)
- Upper Extremity Ischemia(Time of Surgery through Year 2)
- Life Threatening Bleed(Time of Surgery through Year 2)
- Access-related Complications(Time of Surgery through Year 2)
- False Lumen Status - Treated Segment(Time of Surgery through Year 2)
- False Lumen Status - Untreated Segment(Time of Surgery through Year 2)
- False Lumen Perfusion(Time of Surgery through Year 2)