CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

NCT02089607 | Recruiting DMC FDA Device

• 1 other identifier: H-56531
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.

Conditions

Complex Abdominal Aortic Aneurysm; Aortic Arch Aneurysm; Aortic Arch Dissection; Thoracoabdominal Aortic Aneurysm

Keywords

aneurysm; aortic aneurysm

Outcome Measures

Primary Outcomes (2)

• Number of subjects who have died at 30 days post treatment

  Deaths 30 days after treatment

  30 days post treatment

• Number of subjects who experience a Major Adverse Event at 30 days post treatment

  A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.

  30 days post treatment

Secondary Outcomes (2)

• Percentage of subjects who achieve treatment success

  12 months post treatment

• Mean Quality of Life Measure at Various Time Points

  Pre-procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (2)

Complex Abdominal (CAAA) and Thoracoabdominal Aortic Aneurysm (TAAA) Arm

EXPERIMENTAL

The CAAA and TAAA study arm will include 700 patients treated by endovascular aortic repair of CAAAs and TAAAs (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches, with or without concomitant unilateral or bilateral iliac artery aneurysms treated by iliac branch devices. The graft includes 1 to 5 small 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 have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Device: CAAA and TAAA Arm

Aortic Arch Aneurysm Arm

EXPERIMENTAL

Aortic Arch study arm will include 60 patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with CAAAs, TAAAs and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator.

Device: Aortic Arch Aneurysm Arm

Interventions

CAAA and TAAA Arm DEVICE

The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). One or more than one of the study devices including the Zenith® Fenestrated AAA Endovascular Graft, Zenith® t-Branch Endovascular Graft, Patient-Specific Thoracoabdominal Graft, Patient-Specific Distal Bifurcated Component, and Zenith® Branch Endovascular Graft-Iliac Bifurcation will be implanted. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Also known as: Endovascular stent, Stent-graft

Complex Abdominal (CAAA) and Thoracoabdominal Aortic Aneurysm (TAAA) Arm

Aortic Arch Aneurysm Arm DEVICE

The Zenith® Arch Branch Endovascular Graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.

Aortic Arch Aneurysm Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 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.
• Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
• Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.

You may not qualify if:

• 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 \< 2 years
• Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.
• Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated procedure (\> 30 days). Examples include remote (\>30 days) participation in a thoracic, abdominal or iliac branch device trial, or participation in a percutaneous aortic valve trial. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
• Patients with ruptured aortic aneurysms requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.
• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane or gold
• History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated
• Leaking or ruptured aneurysm associated with hypotension
• Uncorrectable coagulopathy
• Mycotic aneurysm or patients with evidence of active systemic infection.
• History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfans syndrome), with the exception of those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular forms of Ehlers Danlos).
• Body habitus that would inhibit X-ray visualization of the aorta and its branches.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• William Cook Australia: collaborator

Study Sites (3)

Mayo Clinic

Rochester, Minnesota, 55905, United States

ACTIVE NOT RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77089, United States

ACTIVE NOT RECRUITING

Related Publications (41)

• 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.

  PMID: 37313951 RESULT

• 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.

  PMID: 39884565 RESULT

• 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.

  PMID: 40054790 RESULT

• 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.

  PMID: 39904414 RESULT

• Rodrigues DVS, Chait J, Cirillo-Penn NC, DeMartino RR, Vierkant RA, Oderich GS, Mendes BC. Trends in hospitalization of patients undergoing endovascular treatment of thoracoabdominal aortic aneurysms based on cerebrospinal fluid drainage strategy. J Vasc Surg. 2024 Oct;80(4):988-995.e1. doi: 10.1016/j.jvs.2024.05.032. Epub 2024 May 19.

  PMID: 38768834 RESULT

• Mesnard T, Sulzer TAL, Kanamori LR, Babocs D, Vacirca A, Baghbani-Oskouei A, Savadi S, Tenorio ER, Mirza A, Saqib N, Mendes B, Macedo T, Verhagen HJM, Huang Y, Oderich GS. Aneurysm sac shrinkage at 1 year after fenestrated-branched endovascular aortic repair of complex aortic aneurysms offers mid-term survival advantage. J Vasc Surg. 2024 Oct;80(4):958-967.e3. doi: 10.1016/j.jvs.2024.05.054. Epub 2024 May 31.

  PMID: 38825213 RESULT

• 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.

  PMID: 39074740 RESULT

• 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.

  PMID: 39584778 RESULT

• 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.

  PMID: 37956958 RESULT

• 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.

  PMID: 38141739 RESULT

• 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.

  PMID: 38897392 RESULT

• Oderich GS, Huang Y, Harmsen WS, Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Gasper WJ, Beck AW, Sweet MP, Lee WA; United States Aortic Research Consortium. Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study. Circulation. 2024 Oct 22;150(17):1343-1353. doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11.

  PMID: 38989575 RESULT

• Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Zettervall SL, Huang Y, Oderich GS; U.S. Fenestrated and Branched Aortic Research Consortium. Effect of bridging stent graft selection for directional branches on target artery outcomes of fenestrated-branched endovascular aortic repair in the United States Aortic Research Consortium. J Vasc Surg. 2023 Jul;78(1):10-28.e3. doi: 10.1016/j.jvs.2023.03.025. Epub 2023 Mar 21.

  PMID: 36948277 RESULT

• Sulzer TAL, Macedo TA, Strissel N, Hesley GK, Lekah A, Tallarita T, Dias-Neto M, Huang Y, Tenorio ER, Vacirca A, Mesnard T, Baghbani-Oskouei A, Savadi S, de Bruin JL, Verhagen HJM, Mendes B, Oderich GS. Changes in renal-mesenteric duplex ultrasound velocities after fenestrated and branched endovascular aortic aneurysm repair. J Vasc Surg. 2023 Nov;78(5):1162-1169.e2. doi: 10.1016/j.jvs.2023.06.106. Epub 2023 Jul 14.

  PMID: 37453587 RESULT

• Wong J, Tenorio ER, Lima G, Dias-Neto M, Baghbani-Oskouei A, Mendes B, Kratzberg J, Ocasio L, Macedo TA, Oderich GS. Early Feasibility of Endovascular Repair of Distal Aortic Arch Aneurysms Using Patient-Specific Single Retrograde Left Subclavian Artery Branch Stent Graft. Cardiovasc Intervent Radiol. 2023 Feb;46(2):249-254. doi: 10.1007/s00270-022-03304-x. Epub 2022 Nov 1.

  PMID: 36319711 RESULT

• 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.

  PMID: 35801701 RESULT

• Rogers RT, Lemmens CC, Tenorio ER, Schurink GWH, DeMartino RR, Oderich GS, Mees BME, Mendes BC. Fenestrated/branched endovascular aortic repair using unilateral femoral access in patients with iliac occlusive disease. J Vasc Surg. 2023 Mar;77(3):722-730. doi: 10.1016/j.jvs.2022.10.049. Epub 2022 Nov 11.

  PMID: 36372375 RESULT

• 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.

  PMID: 36343871 RESULT

• 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.

  PMID: 37080442 RESULT

• 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.

  PMID: 35697310 RESULT

• 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.

  PMID: 35810953 RESULT

• 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.

  PMID: 35181519 RESULT

• 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.

  PMID: 33417331 RESULT

• 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.

  PMID: 32861863 RESULT

• 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.

  PMID: 33548434 RESULT

• 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.

  PMID: 34708266 RESULT

• 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.

  PMID: 33227467 RESULT

• Cajas-Monson L, D'Oria M, Tenorio E, Mendes BC, Oderich GS, DeMartino RR. Effect of renal function on patient survival after endovascular thoracoabdominal and pararenal aortic aneurysm repair. J Vasc Surg. 2021 Jul;74(1):13-19. doi: 10.1016/j.jvs.2020.11.040. Epub 2020 Dec 16.

  PMID: 33340697 RESULT

• 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.

  PMID: 33002587 RESULT

• 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.

  PMID: 34132698 RESULT

• 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.

  PMID: 31980247 RESULT

• 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.

  PMID: 32197996 RESULT

• 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.

  PMID: 32864718 RESULT

• 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.

  PMID: 31611106 RESULT

• 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.

  PMID: 31455986 RESULT

• 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.

  PMID: 30714570 RESULT

• 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.

  PMID: 27866781 RESULT

• 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.

  PMID: 27986479 RESULT

• 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.

  PMID: 26637837 RESULT

• Mendes BC, Oderich GS. Endovascular repair of thoracoabdominal aortic aneurysm using the off-the-shelf multibranched t-Branch stent graft. J Vasc Surg. 2016 May;63(5):1394-1399.e2. doi: 10.1016/j.jvs.2016.02.021.

  PMID: 27109801 RESULT

• de Souza LR, Oderich GS, Banga PV, Hofer JM, Wigham JR, Cha S, Gloviczki P. Outcomes of total percutaneous endovascular aortic repair for thoracic, fenestrated, and branched endografts. J Vasc Surg. 2015 Dec;62(6):1442-9.e3. doi: 10.1016/j.jvs.2015.07.072. Epub 2015 Sep 12.

  PMID: 26372191 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aneurysm, Aortic Arch; Dissection, Thoracic Aorta; Aneurysm; Aortic Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Gustavo S. Oderich, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea C Martinez, MS

CONTACT

713-798-6835; andrea.martinez@bcm.edu

Ying Huang, MD, PhD

CONTACT

832-355-4033; Ying.Huang@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael E. DeBakey Distinguished Endowed Chair in Surgery, Professor of Surgery, Chief of Division of Vascular Surgery and Endovascular Therapy, Director of Baylor Medicine Center for Aortic Surgery, MICHAEL E. DEBAKEY DEPARTMENT OF SURGERY

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: March 1, 2014
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)