Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA) (MPSRA)
Modified Preloaded System for Renal Arteries in Fenestrated Endografting
研究概览
详细说明
Thoracoabdominal aortic aneurysm (TAAA) and complex abdominal aortic aneurysms (AAA) represents an evolving pathology that involves to varying degrees both the descending thoracic aorta and the abdominal aorta. These aneurysms, according to their localization and involvement in the thoracic and abdominal aorta, have been classified according to Crawford into 4 groups (I-IV) for the TAAA and in pararenal/juxtarenal (p/j-AAA) for AAA when a standard endovascular repair is not possible.
The prevalence of these pathologies is currently not well known, but high mortality rates are reported in the population carrying TAAAs and j/p-AAAs that have not undergone surgical treatment, most of which are due to aortic rupture.
Among of the main complications related to TAAA endovascular repair and to complex AAA we can account spinal cord ischemia, lower leg ischemia and logo-operative times, that all can contribute to decrease overall technical and clinical success.
A particular subgroup of TAAAs is represented by post-dissection thoracoabdominal aneurysms (PDTAA), which represents an evolving pathology and one of the main chronic complications in outcomes of acute chronic dissection. In these particular subset of patients, as well as in patient with highly calcified and hostile accesses, the risk of post-operative spinal cord ischemia is higher and the availability of both iliac access navigability is not always possible, leading to technical failure, intraoperative complications and need for adjunctive invasive procedures in high surgical risk patients.
The fenestrated and branched endoprostheses (F/B-EVAR) represent a technology that is now firmly used for the treatment of thoraco-abdominal degenerative aneurysmal pathology in superspecialized centers. Recently, the technology with F/B-EVAR has also been used in the treatment of PDTAA, IMH and PAU, showing satisfactory results. This experience has been carried out in some centers, in the absence, however, of a wider and generalized experience. All these type of endografts are custom-made devices, requiring therefore a lading time for production and delivering before being implanted into the specific patient.
In order to overcome main drawbacks of these procedures, such us long operating time due to fenestrations and vessels cannulation, to avoid bilateral lower limbs ischemia due to large bore introducer sheaths and to accomplish successful delivery even in patient without navigability of both iliac accesses, a modified preloaded system for renal arteries has been developed by Cook (Cook Medical, Bloomington, IN, USA).
The aim of the study is to evaluate in a prospective single center study observational setting, the outcomes, safety and efficacy of the modified preloaded system for renal arteries developed by Cook Medical with bi-port handle system in the field of fenestrated endografting during the routine treatment of thoraco-abdominal and paravisceral abdominal aortic pathologies.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Enrico Gallitto, MD, PhD
- 电话号码:+393330512143288
- 邮箱:enrico.gallitto@gmail.com
学习地点
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Emilia Romagna
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Bologna、Emilia Romagna、意大利、40138
- 招聘中
- University of Bologna
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接触:
- Enrico Gallitto, MD, PhD
- 电话号码:+390512143288
- 邮箱:enrico.gallitto@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Diagnosis of thoraco-abdominal or complex abdominal aortic aneurysm confirmed by a Computed tomography Angiography (CTA).
- Etiologies will be degenerative aneurysms, inflammatory aneurysms, chronic post-dissectional aneurysms, penetrating aortic ulcers, failure of prior surgical or endovascular repair.
- Elective aneurysmal repair of patient with maximum diameter greater than 55 mm, or fast growing, or symptomatic aneurysms.
- Endovascular repair performed using custom-made fenestrated and/or branched endografting with presence of modified preloaded system with modified handle and preloaded catheters for visceral vessels cannulation.
Exclusion Criteria:
- Patients submitted to advanced fenestrated and branched endovascular repair with other grafts besides the Cook Medical custom-made endograft or without modified handle preloaded delivery system.
- Physician-modified devices
- Patient treated with hybrid and/or open technique as well as parallel grafts (such as chimney/snorkel/periscope)
- Patient treated as emergent/urgent patients or aneurysmal rupture
- Patient who can not wait for the lead time required for endograft production and delivery.
学习计划
研究是如何设计的?
设计细节
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 |
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Technical Success
大体时间:Intra-operative final completion angiography.
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Successful deployment of custom-made modified endograft, target vessel patency and aneurysm exclusion, in absence of intra-operative mortality.
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Intra-operative final completion angiography.
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Mortality
大体时间:Within the first 30-days from the procedure.
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Assessment of mortality related to procedure
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Within the first 30-days from the procedure.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cardiovascular Adverse Events
大体时间:Within the first 30-days from the procedure.
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Cardiopulmonary and renal events related to the procedure.
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Within the first 30-days from the procedure.
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Neurologic Adverse Events
大体时间:Within the first 30-days from the procedure.
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Incidence of Spinal Cord Ischemia (transient/permanent) and Stroke
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Within the first 30-days from the procedure.
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Vessel Instability
大体时间:Within the first 30-days from the procedure.
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Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention
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Within the first 30-days from the procedure.
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Rate of early reintervention
大体时间:Within the first 30-days from the procedure.
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Any re-intervention needed after the type of procedure and the specific reason
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Within the first 30-days from the procedure.
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Overall Survival
大体时间:Through study completion, an average of 1 year.
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Assessment of mortality in the post-operative period
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Through study completion, an average of 1 year.
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Aorta Related Survival
大体时间:Through study completion, an average of 1 year.
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Assessment of mortality in the post-operative period related to aortic procedure or aortic related death.
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Through study completion, an average of 1 year.
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Freedom from reintervention
大体时间:Through study completion, an average of 1 year.
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Time from procedure to the first aortic related/procedure related reintervention
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Through study completion, an average of 1 year.
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Freedom from Vessel Instability
大体时间:Through study completion, an average of 1 year.
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Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention
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Through study completion, an average of 1 year.
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Freedom from Major Endoleaks
大体时间:Through study completion, an average of 1 year.
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Time from procedure to the presence of high-flow endoleak (TypeI/III) and from endoleak that required reintervention
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Through study completion, an average of 1 year.
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合作者和调查者
出版物和有用的链接
一般刊物
- Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Ancetti S, Stella A, Abualhin M, Gargiulo M. The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft. J Vasc Surg. 2020 Jul;72(1):16-24. doi: 10.1016/j.jvs.2019.08.273. Epub 2020 Feb 13.
- Gallitto E, Gargiulo M, Faggioli G, Pini R, Mascoli C, Freyrie A, Ancetti S, Stella A. Impact of iliac artery anatomy on the outcome of fenestrated and branched endovascular aortic repair. J Vasc Surg. 2017 Dec;66(6):1659-1667. doi: 10.1016/j.jvs.2017.04.063. Epub 2017 Sep 6.
- Maurel B, Resch T, Spear R, Roeder B, Bracale UM, Haulon S, Mastracci TM. Early experience with a modified preloaded system for fenestrated endovascular aortic repair. J Vasc Surg. 2017 Apr;65(4):972-980. doi: 10.1016/j.jvs.2016.09.045.
- Spanos K, Kolbel T, Kubitz JC, Wipper S, Konstantinou N, Heidemann F, Rohlffs F, Debus SE, Tsilimparis N. Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms. J Vasc Surg. 2019 Feb;69(2):357-366. doi: 10.1016/j.jvs.2018.05.216. Epub 2018 Oct 29.
- Bertoglio L, Loschi D, Grandi A, Melloni A, Bilman V, Melissano G, Chiesa R. Early Limb Reperfusion Using Routinely Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures. Cardiovasc Intervent Radiol. 2020 Dec;43(12):1868-1880. doi: 10.1007/s00270-020-02596-1. Epub 2020 Jul 19.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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近肾主动脉瘤的临床试验
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Augusta Hospital DuesseldorfTel Aviv University; Storz GmbH FRG撤销Infra 和 Juxtarenal 腹主动脉瘤