Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts
NCT ID: NCT01937949
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2013-08-31
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endovascular
The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Other names:
Endovascular stent Stent-graft
Custom-made Zenith® Fenestrated AAA Endovascular Graft:
The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
Interventions
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Custom-made Zenith® Fenestrated AAA Endovascular Graft:
The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
* Aneurysm with a history of growth ≥ 0.5 cm per year
* Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
Exclusion Criteria
* 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 \< 2-years
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Gustavo Oderich
OTHER
Responsible Party
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Gustavo Oderich
Professor
Principal Investigators
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Gustavo Oderich, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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Mayo Clinic
Rochester, Minnesota, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Safa Savadi Osgouei, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HSC-MS-20-0968
Identifier Type: -
Identifier Source: org_study_id