Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of Major Adverse Events
研究概览
简要总结
The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
详细描述
Device Description
Two types of commercially approved thoracic aortic stent-grafts will be modified under the aegis of a physician-sponsored IDE protocol (G200159). The Cook (Bloomington, IN) Zenith Alpha proximal tapered mainbody thoracic stent-grafts and the Cook Zenith TX2 proximal tapered mainbody will be modified to form the fenestrated/branched aortic components. The Alpha thoracic stent-grafts are constructed of woven polyester graft sewn to discrete rows of self-expanding Nitinol Z stents. The most proximal sealing stent is located internally with fixation barbs that protrude through the graft material. The second proximal stent is straight, and the third stent is tapered by 4mm in diameter.
The diameter of the TX2 proximal tapered stent-grafts will range from 32mm to 42mm, depending on the size of the aorta at the proximal seal zone. The lengths will range from 154 to 210mm. The TX2 thoracic stent-grafts are constructed with woven polyester graft sewn to discrete rows of self-expanding stainless steel Z stents. The most proximal seal stent is sewn inside the polyester fabric. The third stent is tapered by either 4mm or 8mm in diameter.
The modification design will be planned using a 3-D multiplanar reconstruction analysis of the CT angiography. Proximal seal zone will be chosen at 2cm disease free parallel aortic walls. Target vessel position will be determined by the longitudinal distance between the proximal extent of the seal zone to the middle of the vessel orifice, as well as radial clock position. Based on these measurements, patient specific modification map will be constructed.
The modification will be designed to incorporate visceral and renal branches, utilizing a various combinations of fenestrations and branch cuffs. The choice between fenestrations and branch cuffs will be made based on the aortic size and angulation at the level of the target branches. For example, when the target branches are within the seal zone, fenestrations will be chosen. Conversely, branch cuffs will be incorporated onto the mainbody if the aorta at the level of the target branches is aneurysmal, or angulated where precise three dimensional position of the target branch, hence fenestration, along the implanted stent graft is difficult to predict.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts.
- •Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.
- •Aneurysm with a history of growth ≥ 0.5cm per year.
- •Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
- •Symptomatic aneurysm without hemodynamic instability
- •Aneurysms meeting any of the above criteria 1~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.
排除标准
- •Patients must be excluded from the study if any of the following conditions is true:
- •Less than 18 years of age.
- •Unwilling to comply with the follow-up schedule.
- •Inability or refusal to give informed consent by the patient or a legally authorized representative.
- •Pregnant or breastfeeding.
- •Life-expectancy less than 2 years.
- •Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (>30 days). Examples include remote (>30days) participation in a thoracic, or abdominal branch device trial.
- •Eligible for treatment with FDA-approved marketed device.
- •Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.
结局指标
主要结局
Rate of Major Adverse Events
时间窗: Immediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included.
1. Aortic rupture within 30 days 2. Lesion-related mortality within 30 days 3. All-cause mortality within 30 days 4. Permanent paraplegia, defined by lack of resolution at 1 month follow-up 5. Permanent paraparesis, defined by lack of resolution at 1 month follow-up 6. Renal function decline resulting in \> 50% of estimated Glomerular Filtration Rate or New onset renal failure requiring dialysis, defined by ongoing dialysis at 1 month follow-up 7. Severe bowel ischemia, requiring laparotomy 8. Disabling stroke, reported within 30 days of the procedure, without resolution at 90 days post-procedure 9. Myocardial infarction 10. Respiratory failure requiring prolonged (\> 24 hours from anticipated) mechanical ventilation or reintubation
次要结局
- Rate of Treatment Success(30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years)
- Rate of Technical Success(Immediately after the surgery)
研究者
Sukgu Han, MD, MS
Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, University of Southern California
University of Southern California