有孔覆膜支架修复复杂腹主动脉瘤
2026年1月16日 更新者：Gustavo S Oderich
有孔支架移植物治疗复杂腹主动脉瘤患者的临床结果和生活质量测量
本研究的目的是评估使用定制的 Cook Zenith® Fenestrated AAA 血管内移植物对近肾、肾上和 IV 型胸腹主动脉瘤进行血管内修复治疗的临床结果和生活质量指标。
研究概览
详细说明
这是一项传统的设备可行性研究，旨在生成初步的安全性和有效性信息，这些信息可用于规划适当的未来研究，或为进一步的产品开发提供信息。
研究类型
介入性
注册 (估计的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Andrea C Martinez, MS
- 电话号码：713-798-6835
- 邮箱：andrea.martinez@bcm.edu
研究联系人备份
- 姓名：Ying Huang, MD, PhD
- 电话号码：832-355-4033
- 邮箱：Ying.Huang@bcm.edu
学习地点
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- 主动，不招人
- Mayo Clinic
-
-
Texas
-
Houston、Texas、美国、77030
- 招聘中
- The University of Texas Health Science Center at Houston
-
接触：
- Mariano R Montemayor, MD, MHA, CCRP
- 电话号码：(713) 486-5194
- 邮箱：Mariano.R.Montemayor@uth.tmc.edu
-
首席研究员：
- Naveed U Saqib, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
一般纳入标准
- 如果患者至少具有以下一项并且适合使用定制的 Zenith® Fenestrated AAA 血管内移植物进行治疗，则该患者可能会被纳入研究：
- 直径 ≥ 5.0 cm 或正常主动脉直径 2 倍的近肾、肾上或 IV 型胸腹主动脉瘤
- 有每年 ≥ 0.5 cm 生长史的动脉瘤
- 根据医生的解释，囊状动脉瘤被认为有很大的破裂风险。
一般排除标准
- 未满 18 岁
- 不愿遵守后续时间表
- 患者或合法授权代表无法或拒绝给予知情同意
- 怀孕或哺乳
- 预期寿命 < 2 年
- 临床调查计划中指定的其他医疗限制
- 临床研究计划中规定的额外解剖学限制
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：血管内
该研究将包括使用定制的 Cook Zenith® Fenestrated AAA 血管内移植物对近肾、肾上和 IV 型胸腹主动脉瘤进行血管内主动脉修复治疗的患者。 移植物包括扇贝、孔（开窗）或袖口（侧枝）的组合。 这些小孔或树枝是本研究的调查部分。 肝脏、肠道和肾脏的动脉将有一个支架（小管状不锈钢结构），以帮助保持动脉开放并与开窗或分支对齐。 其他名称： 血管内支架 Stent-graft |
移植物将通过腹股沟的动脉插入（称为血管内修复）。
血管内修复是一种使用进入血管内部的导管在动脉瘤上方和下方放置覆膜支架的手术。
这个过程用新的衬里（支架）衬在动脉瘤上，这样血液就不会再充满动脉。
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
治疗后 30 天死亡的受试者人数
大体时间：治疗后30天]
|
治疗后 30 天死亡
|
治疗后30天]
|
|
治疗后 30 天发生主要不良事件的受试者人数
大体时间：治疗后30天
|
主要不良事件包括以下任何一种：肠缺血、心肌梗塞（心脏病发作）、截瘫、肾衰竭、呼吸衰竭、中风或失血超过 1000 毫升。
|
治疗后30天
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Short Form-36 (SF-36) 生活质量问卷的科目分数
大体时间：基线、6周、6个月、1年、2年、3年、4年、5年。
|
受试者完成了 SF-36，其中包含 8 个子量表，这些子量表另外总结为 2 个摘要部分（身体和心理）。
子量表和汇总量表的范围都是从 0 到 100，其中（0 = 最差的想象，100 = 最好的想象）。
|
基线、6周、6个月、1年、2年、3年、4年、5年。
|
|
取得治疗成功的受试者人数
大体时间：12个月
|
治疗成功由复合终点定义，其中包括下述所有标准：
|
12个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Gustavo S. Oderich, MD、Baylor College of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Finnesgard EJ, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Simons JP, Schanzer A; United States Aortic Research Consortium. Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Oct;78(4):892-901. doi: 10.1016/j.jvs.2023.05.034. Epub 2023 Jun 16.
- Aucoin VJ, Motyl CM, Novak Z, Eagleton MJ, Farber MA, Gasper W, Oderich GS, Mendes B, Schanzer A, Tenorio E, Timaran CH, Schneider DB, Sweet MP, Zettervall SL, Beck AW; U.S. Aortic Research Consortium. Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium. J Vasc Surg. 2023 Jun;77(6):1578-1587. doi: 10.1016/j.jvs.2023.01.205. Epub 2023 Apr 13.
- Banga P, Oderich GS, Farber M, Reis de Souza L, Tenorio ER, Timaran C, Schneider DB, Baumgardt Barbosa Lima G, Barreira Marcondes G, Timaran D. Impact of Number of Vessels Targeted on Outcomes of Fenestrated-Branched Endovascular Repair for Complex Abdominal Aortic Aneurysms. Ann Vasc Surg. 2021 Apr;72:98-105. doi: 10.1016/j.avsg.2020.09.063. Epub 2020 Nov 21.
- Chait J, Tenorio ER, Kawajiri H, Lima GBB, Cirillo-Penn NC, Bagameri G, Pochettino A, DeMartino RR, Oderich GS, Mendes BC. Mid-Term Outcomes of "Complete Aortic Repair": Surgical or Endovascular Total Arch Replacement With Thoracoabdominal Fenestrated-Branched Endovascular Aortic Repair. J Endovasc Ther. 2025 Apr;32(2):503-512. doi: 10.1177/15266028231181211. Epub 2023 Jun 14.
- Cirillo-Penn NC, MacArthur TA, Tenorio ER, DeMartino RR, Macedo TA, Oderich GS, Mendes BC. Outcomes of patients treated with double-wide scallop vs fenestrations for celiac artery incorporation during repair of complex abdominal aortic aneurysms. J Vasc Surg. 2025 May;81(5):1033-1039. doi: 10.1016/j.jvs.2025.01.194. Epub 2025 Jan 28.
- Vacirca A, Mesnard T, Huang Y, Mendes BC, Jakimowicz T, Schneider DB, Haulon S, Sobocinski J, Beck AW, Schanzer A, Farber MA, Timaran C, Kahlberg A, Kolbel T, Gasper WJ, Mees BME, Gargiulo M, Dias NV, Woongchae AL, Sweet MP, Mani K, Eagleton M, Pedro LM, Verhagen H, Yeung KK, Tsilimparis N, Resch T, Bertoglio L, Ferreira E, Khashram M, Sulzer T, Dias-Neto M, Tenorio ER, Kanamori LR, Jama K, Parodi E, Gomes V, Colon JP, Chiesa R, Panuccio G, Schurink GW, Lemmens C, Gallitto E, Faggioli G, Karelis A, Wanhainen A, Habib M, Gouveia E Melo R, Kappe KO, Mariko van Knippenberg SE, Tran B, Crawford S, Panagrosso M, Melloni A, Bonardelli S, Garcia R, Ribeiro T, Gormley S, Maximus S, Oderich GS; International Multicenter Aortic Research Group. Predictors of failure to rescue after fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2025 Jul;82(1):32-42.e3. doi: 10.1016/j.jvs.2025.02.032. Epub 2025 Mar 5.
- Ruiter Kanamori L, Tenorio E, Babocs D, Lima GB, Mendes B, Macedo TA, Maximus S, Huang Y, Oderich GS. Clinical outcomes and quality of life measures among 5-year survivors of fenestrated-branched endovascular aortic repair. J Vasc Surg. 2025 Jun;81(6):1254-1265. doi: 10.1016/j.jvs.2025.01.210. Epub 2025 Feb 2.
- Ruiter Kanamori L, Tenorio ER, Babocs D, Savadi S, Baghbani-Oskouei A, Huang Y, Figueroa A, Tanenbaum M, Costa Filho JE, Baig M, Macedo TA, Timaran CH, Oderich GS. Indications, safety, and effectiveness of transcatheter electrosurgical septotomy during endovascular repair of aortic dissections. J Vasc Surg. 2024 Nov;80(5):1396-1406. doi: 10.1016/j.jvs.2024.07.089. Epub 2024 Jul 27.
- Huang Y, Colglazier J, Mendes BC, Pochettino A, Kalra M, Greason KL, Tenorio ER, Harmsen WS, Oderich GS. Target Artery Outcomes Following Endovascular versus Open Surgical Repair of Thoracoabdominal Aortic Aneurysms - A Single Center Comparative Study. Ann Surg. 2024 Nov 25. doi: 10.1097/SLA.0000000000006594. Online ahead of print.
- Steadman JA, Tenorio ER, Chait J, Vierkant RA, DeMartino RR, Oderich GS, Mendes BC. Preoperative predictors of nonhome discharge after fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2024 Mar;79(3):469-477.e3. doi: 10.1016/j.jvs.2023.11.015. Epub 2023 Nov 11.
- Mesnard T, Vacirca A, Baghbani-Oskouei A, Sulzer TAL, Savadi S, Kanamori LR, Tenorio ER, Mirza A, Saqib N, Mendes BC, Huang Y, Oderich GS. Prospective evaluation of upper extremity access and total transfemoral approach during fenestrated and branched endovascular repair. J Vasc Surg. 2024 May;79(5):1013-1023.e3. doi: 10.1016/j.jvs.2023.12.033. Epub 2023 Dec 21.
- Tanenbaum MT, Figueroa AV, Kanamori LR, Costa Filho JE, Soto Gonzalez M, Sulzer T, Mesnard T, Huang Y, Baig MS, Oderich GS, Timaran CH. Early experience with patient-specific unibody bifurcated fenestrated-branched devices for complex endovascular aortic aneurysm repair. J Vasc Surg. 2024 Nov;80(5):1361-1370. doi: 10.1016/j.jvs.2024.06.020. Epub 2024 Jun 17.
- Tenorio ER, Mirza AK, Lima GBB, Marcondes GB, Wong J, Mendes BC, Saqib N, Khan S, Macedo TA, Oderich GS. Characterization of Secondary Interventions After Fenestrated-branched Endovascular Repair of Complex Aortic Aneurysms and Its Effect on Quality of Life and Patient Survival. Ann Surg. 2023 Jul 1;278(1):140-147. doi: 10.1097/SLA.0000000000005454. Epub 2022 Jul 8.
- Dias-Neto M, Marcondes G, Tenorio ER, Barbosa Lima GB, Baghbani-Oskouei A, Vacirca A, Mendes BC, Saqib N, Mirza AK, Oderich GS. Outcomes of iliofemoral conduits during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Mar;77(3):712-721.e1. doi: 10.1016/j.jvs.2022.10.050. Epub 2022 Nov 5.
- Vacirca A, Wong J, Baghbani-Oskouei A, Tenorio ER, Huang Y, Mirza A, Saqib N, Sulzer T, Mesnard T, Mendes BC, Oderich GS. Outcomes of fenestrated-branched endovascular aortic repair in patients with or without prior history of abdominal endovascular or open surgical repair. J Vasc Surg. 2023 Aug;78(2):278-288.e3. doi: 10.1016/j.jvs.2023.04.001. Epub 2023 Apr 19.
- Paajanen P, Karkkainen JM, Tenorio ER, Mendes BC, Oderich GS. Effect of patient frailty status on outcomes of fenestrated-branched endovascular aortic repair for complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2022 Nov;76(5):1170-1179.e2. doi: 10.1016/j.jvs.2022.05.008. Epub 2022 Jun 11.
- Dias-Neto M, Tenorio ER, Lima GBB, Baghbani-Oskouei A, Saqib N, Mendes BC, Mirza AK, Oderich GS. Outcomes of low- and standard-profile fenestrated and branched stent grafts for treatment of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2022 Nov;76(5):1160-1169.e1. doi: 10.1016/j.jvs.2022.05.028. Epub 2022 Jul 8.
- Chait J, Tenorio ER, Mendes BC, Barbosa Lima GB, Marcondes GB, Wong J, Macedo TA, De Martino RR, Oderich GS. Impact of gap distance between fenestration and aortic wall on target artery instability following fenestrated-branched endovascular aortic repair. J Vasc Surg. 2022 Jul;76(1):79-87.e4. doi: 10.1016/j.jvs.2022.01.135. Epub 2022 Feb 16.
- Tenorio ER, Ribeiro MS, Banga PV, Mendes BC, Karkkainen J, DeMartino RR, Hoffman EM, Oderich GS. Prospective Assessment of a Protocol Using Neuromonitoring, Early Limb Reperfusion, and Selective Temporary Aneurysm Sac Perfusion to Prevent Spinal Cord Injury During Fenestrated-branched Endovascular Aortic Repair. Ann Surg. 2022 Dec 1;276(6):e1028-e1034. doi: 10.1097/SLA.0000000000004624. Epub 2021 Jan 7.
- Squizzato F, Oderich GS, Tenorio ER, Mendes BC, DeMartino RR. Effect of celiac axis compression on target vessel-related outcomes during fenestrated-branched endovascular aortic repair. J Vasc Surg. 2021 Apr;73(4):1167-1177.e1. doi: 10.1016/j.jvs.2020.07.092. Epub 2020 Aug 27.
- Squizzato F, Oderich GS, Balachandran P, Tenorio ER, Mendes BC, De Martino RR. Effect of aortic angulation on the outcomes of fenestrated-branched endovascular aortic repair. J Vasc Surg. 2021 Aug;74(2):372-382.e3. doi: 10.1016/j.jvs.2021.01.027. Epub 2021 Feb 4.
- Marcondes GB, Tenorio ER, Baumgardt G, Mendes B, Oderich GS. Evaluation of Safety of Overhead Upper Extremity Positioning During Fenestrated-Branched Endovascular Repair of Thoracoabdominal Aortic Aneurysms. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1895-1902. doi: 10.1007/s00270-021-02992-1. Epub 2021 Oct 27.
- Karkkainen JM, Oderich GS, Tenorio ER, Pather K, Oksala N, Macedo TA, Vrtiska T, Mees B, Jacobs MJ. Psoas muscle area and attenuation are highly predictive of complications and mortality after complex endovascular aortic repair. J Vasc Surg. 2021 Apr;73(4):1178-1188.e1. doi: 10.1016/j.jvs.2020.08.141. Epub 2020 Sep 28.
- Oderich GS, Tenorio ER, Mendes BC, Lima GBB, Marcondes GB, Saqib N, Hofer J, Wong J, Macedo TA. Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts. Ann Surg. 2021 Sep 1;274(3):491-499. doi: 10.1097/SLA.0000000000004982.
- Karkkainen JM, Tenorio ER, Jain A, Mendes BC, Macedo TA, Pather K, Gloviczki P, Oderich GS. Outcomes of target vessel endoleaks after fenestrated-branched endovascular aortic repair. J Vasc Surg. 2020 Aug;72(2):445-455. doi: 10.1016/j.jvs.2019.09.055. Epub 2020 Jan 21.
- Karkkainen JM, Tenorio ER, Pather K, Mendes BC, Macedo TA, Wigham J, Diderrich A, Oderich GS. Outcomes of Small Renal Artery Targets in Patients Treated by Fenestrated-Branched Endovascular Aortic Repair. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):910-917. doi: 10.1016/j.ejvs.2020.02.015. Epub 2020 Mar 18.
- Sen I, Tenorio ER, Mirza AK, Karkkainen JM, Mendes BC, DeMartino RR, Cha S, Oderich GS. Effect of Blood Loss and Transfusion Requirements on Clinical Outcomes of Fenestrated-Branched Endovascular Aortic Repair. Cardiovasc Intervent Radiol. 2020 Nov;43(11):1600-1607. doi: 10.1007/s00270-020-02573-8. Epub 2020 Aug 30.
- Tenorio ER, Karkkainen JM, Mendes BC, DeMartino RR, Macedo TA, Diderrich A, Hofer J, Oderich GS. Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1489-1502.e6. doi: 10.1016/j.jvs.2019.07.079. Epub 2019 Oct 11.
- Chini J, Mendes BC, Tenorio ER, Ribeiro MS, Sandri GA, Cha S, Hofer J, Oderich GS. Preloaded Catheters and Guide-Wire Systems to Facilitate Catheterization During Fenestrated and Branched Endovascular Aortic Repair. Cardiovasc Intervent Radiol. 2019 Dec;42(12):1678-1686. doi: 10.1007/s00270-019-02322-6. Epub 2019 Aug 27.
- Karkkainen JM, Sandri GA, Tenorio ER, Macedo TA, Hofer J, Gloviczki P, Cha S, Oderich GS. Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts. J Vasc Surg. 2019 May;69(5):1356-1366.e6. doi: 10.1016/j.jvs.2018.07.060. Epub 2018 Oct 24.
- Oderich GS, Ribeiro M, Reis de Souza L, Hofer J, Wigham J, Cha S. Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts. J Thorac Cardiovasc Surg. 2017 Feb;153(2):S32-S41.e7. doi: 10.1016/j.jtcvs.2016.10.008. Epub 2016 Oct 22.
- Oderich GS, Ribeiro M, Hofer J, Wigham J, Cha S, Chini J, Macedo TA, Gloviczki P. Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones. J Vasc Surg. 2017 May;65(5):1249-1259.e10. doi: 10.1016/j.jvs.2016.09.038. Epub 2016 Dec 13.
- Banga PV, Oderich GS, Reis de Souza L, Hofer J, Cazares Gonzalez ML, Pulido JN, Cha S, Gloviczki P. Neuromonitoring, Cerebrospinal Fluid Drainage, and Selective Use of Iliofemoral Conduits to Minimize Risk of Spinal Cord Injury During Complex Endovascular Aortic Repair. J Endovasc Ther. 2016 Feb;23(1):139-49. doi: 10.1177/1526602815620898. Epub 2015 Dec 4.
- Finnesgard EJ, Jones DW, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Schanzer A; United States Aortic Research Consortium. Trends and outcomes over time with fenestrated and branched endovascular aortic repair in the United States Aortic Research Consortium. J Vasc Surg. 2025 Jun;81(6):1235-1243. doi: 10.1016/j.jvs.2025.01.213. Epub 2025 Feb 4.
- Mesnard T, Huang Y, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zetterval SL, Lee A, Oderich GS; United States Aortic Research Consortium. Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience. Ann Surg. 2025 Feb 18. doi: 10.1097/SLA.0000000000006676. Online ahead of print.
- Blakeslee-Carter J, Novak Z, Jansen JO, Schanzer A, Eagleton MJ, Farber MA, Gasper W, Lee WA, Oderich GS, Timaran CH, Schneider DB, Sweet MP, Beck AW. Prospective randomized pilot trial comparing prophylactic and therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2024 Jul;80(1):11-19. doi: 10.1016/j.jvs.2024.02.041. Epub 2024 Apr 6.
- Jain V, Banga P, Vallabhaneni R, Eagleton M, Oderich G, Farber MA. Endovascular treatment of aneurysms using fenestrated-branched endografts with distal inverted iliac limbs. J Vasc Surg. 2016 Sep;64(3):600-4. doi: 10.1016/j.jvs.2016.02.058.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年8月1日
初级完成 (实际的)
2025年3月1日
研究完成 (估计的)
2030年5月1日
研究注册日期
首次提交
2013年9月4日
首先提交符合 QC 标准的
2013年9月4日
首次发布 (估计的)
2013年9月10日
研究记录更新
最后更新发布 (实际的)
2026年1月20日
上次提交的符合 QC 标准的更新
2026年1月16日
最后验证
2026年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.