Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

NCT02323581 | Recruiting DMC

• 1 other identifier: 843522
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm, Thoracic; Aortic Dissection, Thoracoabdominal

Keywords

Thoracoabdominal; Aneurysm; Endovascular; Stent-Graft; Aortic Arch; BEVAR; FEVAR; Aorta; Aortic Dissection

Outcome Measures

Primary Outcomes (4)

• Technical Success

  Successful deployment of the TAAA device or Physician-Specified TAAA Devices, or Aortic Arch device \& bridging covered stents into all targeted mesenteric \& renal, or supra-aortic arteries with stent-graft \& all branches patent by intraop angiography

  Intraoperative

• Procedural Success

  Technical success plus freedom from type I or III endoleak, loss of target vessel patency, death, major stroke, paralysis, new onset permanent hemodialysis, major amputation, \& bowel infarction following deployment of the branched stent-graft.

  30 days

• Freedom from aneurysm-related mortality at 1 year

  Survival from aneurysm-related death.

  1 year

• Treatment success at 12 months post-procedure

  Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality

  1 year

Secondary Outcomes (14)

• Target artery patency

  Yearly through 5 years

• Freedom from all-cause mortality

  Yearly through 5 years

• Freedom from reintervention

  Yearly through 5 years

• Freedom from endoleak

  Yearly through 5 years

• Freedom from aneurysm dilatation

  Yearly through 5 years

Study Arms (2)

TAAA (thoracoabdominal aortic aneurysm) Study Arm

EXPERIMENTAL

Either the Off-the-Shelf TAAA device or the Physician-Specified TAAA Device will be implanted. The Off-the-Shelf TAAA Device is a standard configuration Zenith t-Branch with four branches for the mesenteric arteries and the renal arteries. The Physician-Specified TAAA Devices may include a combination of up to 5 fenestrations and branches for mesenteric and renal arteries. Branches will be used for downward-oriented mesenteric and renal arteries and fenestrations for renal arteries that project laterally or upwards.

Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm

Aortic Arch Study Arm

EXPERIMENTAL

Physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or a physician-specified retrograde left subclavian branch stent-graft with double or triple wide scallop to the left common carotid artery\] to treat aortic aneurysms involving the aortic arch in patients at high risk for open surgery.

Device: Endovascular treatment of Aortic Arch Aneurysms

Interventions

Endovascular treatment of Thoracoabdominal Aortic Aneurysm DEVICE

A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached. This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called "fenestrations") that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm.

TAAA (thoracoabdominal aortic aneurysm) Study Arm

Endovascular treatment of Aortic Arch Aneurysms DEVICE

An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms. The 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.

Aortic Arch Study Arm

Eligibility Criteria

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

You may qualify if:

• Presence of TAAA in:
• Men with TAAA greater than or equal to 6 cm in diameter
• Women with TAAA greater than or equal to 5 cm in diameter
• Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
• Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
• Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
• Life expectancy more than 2 years
• Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
• Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
• Proximal aortic landing zone:
• ≥ 20mm long
• ≤ 40mm and ≥ 20mm diameter in parallel aorta
• free from circumferential thrombus
• ≤ 60 degrees angulation
• Mesenteric/renal aortic diameter ≥ 20mm

You may not qualify if:

• Rupture, with hypotension (systolic bp \< 90).
• Pregnancy or breastfeeding.
• Unwillingness or inability to comply with the follow up schedule.
• Serious systemic or groin infection.
• Uncorrectable coagulopathy.
• Age \< 18 years.
• Mycotic aneurysm.
• Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
• Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
• Participation in another in another investigational device or drug study within 1 year of treatment.
• Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)
• Body habitus that would inhibit X-ray visualization of the aorta.
• Acute aortic dissection
• Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

Sponsors & Collaborators

• Darren Schneider, M.D.: lead

Study Sites (2)

New York Presbyterian Hospital

New York, New York, 10022, United States

ACTIVE NOT RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (26)

• Meltzer AJ, Connolly PH, Ellozy S, Schneider DB. Patient-reported Quality of Life after Endovascular Repair of Thoracoabdominal Aortic Aneurysms. Ann Vasc Surg. 2017 Oct;44:164-170. doi: 10.1016/j.avsg.2017.04.009. Epub 2017 May 17.

  PMID: 28527678 BACKGROUND

• Stern JR, Ellozy SH, Connolly PH, Meltzer AJ, Schneider DB. Utility and safety of axillary conduits during endovascular repair of thoracoabdominal aneurysms. J Vasc Surg. 2017 Sep;66(3):705-710. doi: 10.1016/j.jvs.2016.12.107. Epub 2017 Mar 1.

  PMID: 28259569 BACKGROUND

• Schneider DB, Agrusa CJ, Ellozy SH, Connolly PH, Meltzer AJ, Graham AR, Michelassi F. Analysis of the Learning Curve and Patient Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms Using Fenestrated and Branched Stent Grafts: Prospective, Nonrandomized, Single-center Physician-sponsored Investigational Device Exemption Clinical Study. Ann Surg. 2018 Oct;268(4):640-649. doi: 10.1097/SLA.0000000000002960.

  PMID: 30080733 BACKGROUND

• Dias-Neto M, Vacirca A, Huang Y, Baghbani-Oskouei A, Jakimowicz T, Mendes BC, Kolbel T, Sobocinski J, Bertoglio L, Mees B, Gargiulo M, Dias N, Schanzer A, Gasper W, Beck AW, Farber MA, Mani K, Timaran C, Schneider DB, Pedro LM, Tsilimparis N, Haulon S, Sweet MP, Ferreira E, Eagleton M, Yeung KK, Khashram M, Jama K, Panuccio G, Rohlffs F, Mesnard T, Chiesa R, Kahlberg A, Schurink GW, Lemmens C, Gallitto E, Faggioli G, Karelis A, Parodi E, Gomes V, Wanhainen A, Habib M, Colon JP, Pavarino F, Baig MS, Gouveia E Melo REC, Crawford S, Zettervall SL, Garcia R, Ribeiro T, Alves G, Goncalves FB, Kappe KO, Mariko van Knippenberg SE, Tran BL, Gormley S, Oderich GS; International Multicenter Aortic Research Group. Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms. Ann Surg. 2023 Oct 1;278(4):568-577. doi: 10.1097/SLA.0000000000005986. Epub 2023 Jul 3.

  PMID: 37395613 BACKGROUND

• 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.

  PMID: 37330702 BACKGROUND

• Abdelhalim MA, Tenorio ER, Oderich GS, Haulon S, Warren G, Adam D, Claridge M, Butt T, Abisi S, Dias NV, Kolbel T, Gallitto E, Gargiulo M, Gkoutzios P, Panuccio G, Kuzniar M, Mani K, Mees BM, Schurink GW, Sonesson B, Spath P, Wanhainen A, Schanzer A, Beck AW, Schneider DB, Timaran CH, Eagleton M, Farber MA, Modarai B; Multicenter International Aortic Research Group. Multicenter trans-Atlantic experience with fenestrated-branched endovascular aortic repair of chronic post-dissection thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Oct;78(4):854-862.e1. doi: 10.1016/j.jvs.2023.05.053. Epub 2023 Jun 13.

  PMID: 37321524 BACKGROUND

• 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.

  PMID: 37059239 BACKGROUND

• Tenorio ER, Schanzer A, Timaran CH, Schneider DB, Mendes BC, Eagleton MJ, Farber MA, Parodi FE, Gasper WJ, Beck AW, Sweet MP, Huang Y, Oderich GS; U.S. Fenestrated and Branched Aortic Research Consortium. Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in the United States Aortic Research Consortium. Ann Surg. 2023 Oct 1;278(4):e893-e902. doi: 10.1097/SLA.0000000000005859. Epub 2023 Apr 13.

  PMID: 37051912 BACKGROUND

• 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 BACKGROUND

• Heslin RT, Blakeslee-Carter J, Novak Z, Eagleton MJ, Farber MA, Oderich GS, Schanzer A, Timaran CH, Schneider DB, Sweet MP, Beck AW. Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Quality Initiative and the United States Aortic Research Consortium. J Vasc Surg. 2023 Jul;78(1):1-9.e3. doi: 10.1016/j.jvs.2023.02.020. Epub 2023 Mar 14.

  PMID: 36921644 BACKGROUND

• Dias-Neto M, Tenorio ER, Huang Y, Jakimowicz T, Mendes BC, Kolbel T, Sobocinski J, Bertoglio L, Mees B, Gargiulo M, Dias N, Schanzer A, Gasper W, Beck AW, Farber MA, Mani K, Timaran C, Schneider DB, Pedro LM, Tsilimparis N, Haulon S, Sweet M, Ferreira E, Eagleton M, Yeung KK, Khashram M, Vacirca A, Lima GB, Baghbani-Oskouei A, Jama K, Panuccio G, Rohlffs F, Chiesa R, Schurink GW, Lemmens C, Gallitto E, Faggioli G, Karelis A, Parodi E, Gomes V, Wanhainen A, Dean A, Colon JP, Pavarino F, E Melo RG, Crawford S, Garcia R, Ribeiro T, Kappe KO, van Knippenberg SEM, Tran BL, Gormley S, Oderich GS; International Aortic Research Consortium. Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2023 Jun;77(6):1588-1597.e4. doi: 10.1016/j.jvs.2023.01.188. Epub 2023 Jan 31.

  PMID: 36731757 BACKGROUND

• Chamseddin K, Timaran CH, Oderich GS, Tenorio ER, Farber MA, Parodi FE, Schneider DB, Schanzer A, Beck AW, Sweet MP, Zettervall SL, Mendes B, Eagleton MJ, Gasper WJ; U.S. Aortic Research Consortium. Comparison of upper extremity and transfemoral access for fenestrated-branched endovascular aortic repair. J Vasc Surg. 2023 Mar;77(3):704-711. doi: 10.1016/j.jvs.2022.10.009. Epub 2022 Oct 17.

  PMID: 36257344 BACKGROUND

• Zettervall SL, Tenorio ER, Schanzer A, Oderich GS, Timaran CH, Schneider DB, Eagleton M, Farber MA, Gasper WJ, Beck AW, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium. Secondary interventions after fenestrated/branched aneurysm repairs are common and nondetrimental to long-term survival. J Vasc Surg. 2022 May;75(5):1530-1538.e4. doi: 10.1016/j.jvs.2021.11.074. Epub 2021 Dec 23.

  PMID: 34954272 BACKGROUND

• Edman NI, Schanzer A, Crawford A, Oderich GS, Farber MA, Schneider DB, Timaran CH, Beck AW, Eagleton M, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium. Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium. J Vasc Surg. 2021 Sep;74(3):861-870. doi: 10.1016/j.jvs.2021.02.046. Epub 2021 Mar 26.

  PMID: 33775747 BACKGROUND

• Timaran CH, Oderich GS, Tenorio ER, Farber MA, Schneider DB, Schanzer A, Beck AW, Sweet MP; Aortic Research Consortium. Expanded Use of Preloaded Branched and Fenestrated Endografts for Endovascular Repair of Complex Aortic Aneurysms. Eur J Vasc Endovasc Surg. 2021 Feb;61(2):219-226. doi: 10.1016/j.ejvs.2020.11.001. Epub 2020 Nov 28.

  PMID: 33262091 BACKGROUND

• 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 BACKGROUND

• Aucoin VJ, Eagleton MJ, Farber MA, Oderich GS, Schanzer A, Timaran CH, Schneider DB, Sweet MP, Beck AW. Spinal cord protection practices used during endovascular repair of complex aortic aneurysms by the U.S. Aortic Research Consortium. J Vasc Surg. 2021 Jan;73(1):323-330. doi: 10.1016/j.jvs.2020.07.107. Epub 2020 Aug 31.

  PMID: 32882346 BACKGROUND

• Kitpanit N, Ellozy SH, Connolly PH, Agrusa CJ, Lichtman AD, Schneider DB. Risk factors for spinal cord injury and complications of cerebrospinal fluid drainage in patients undergoing fenestrated and branched endovascular aneurysm repair. J Vasc Surg. 2021 Feb;73(2):399-409.e1. doi: 10.1016/j.jvs.2020.05.070. Epub 2020 Jul 5.

  PMID: 32640318 BACKGROUND

• Tenorio ER, Oderich GS, Farber MA, Schneider DB, Timaran CH, Schanzer A, Beck AW, Motta F, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium Investigators. Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts. J Vasc Surg. 2020 Sep;72(3):822-836.e9. doi: 10.1016/j.jvs.2019.10.091. Epub 2019 Dec 25.

  PMID: 31882309 BACKGROUND

• Agrusa CJ, Connolly PH, Ellozy SH, Schneider DB. Safety and Effectiveness of Percutaneous Axillary Artery Access for Complex Aortic Interventions. Ann Vasc Surg. 2019 Nov;61:326-333. doi: 10.1016/j.avsg.2019.05.046. Epub 2019 Aug 5.

  PMID: 31394224 BACKGROUND

• Banks CA, Novak Z, Spangler EL, Schanzer A, Farber MA, Sweet MP, Oderich G, Timaran CH, Lee A, Schneider DB, Eagleton MJ, Gasper W, Beck AW. Preoperative risk factors for 1-year mortality in patients undergoing fenestrated endovascular aortic aneurysm repair in the US Aortic Research Consortium. J Vasc Surg. 2024 Sep;80(3):724-735.e3. doi: 10.1016/j.jvs.2024.04.063. Epub 2024 May 6.

  PMID: 38718849 BACKGROUND

• 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.

  PMID: 38614137 BACKGROUND

• Fan EY, Schanzer A, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Parodi FE, Schneider DB, Sweet MP, Timaran CH, Simons JP; US Aortic Research Consortium. Practice patterns of antiplatelet and anticoagulant therapy after fenestrated/branched endovascular aortic repair. J Vasc Surg. 2024 Oct;80(4):968-978.e3. doi: 10.1016/j.jvs.2024.05.041. Epub 2024 May 23.

  PMID: 38796031 BACKGROUND

• 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 BACKGROUND

• Al Adas Z, Uceda D, Mazur A, Zehner K, Agrusa CJ, Wang G, Schneider DB. Safety and learning curve of percutaneous axillary artery access for complex endovascular aortic procedures. J Vasc Surg. 2024 Mar;79(3):487-496. doi: 10.1016/j.jvs.2023.10.048. Epub 2023 Oct 31.

  PMID: 37918698 BACKGROUND

• 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.

  PMID: 39963789 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Darren Schneider, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darren Schneider, MD

CONTACT

215-614-0243; Darren.Schneider@Pennmedicine.upenn.edu

Kiera Zehner

CONTACT

(412) 737-2572; kiera.zehner@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Vascular Surgery and Endovascular Therapy

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: November 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (2)