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

Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm, Thoracic; Aortic Aneurysm, Thoracoabdominal; Aortic Dissection, Thoracoabdominal
• Intervention / Treatment: Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm; Device: Endovascular treatment of Aortic Arch Aneurysms

Detailed Description

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 in two study arms:

1. TAAA (thoracoabdominal aortic aneurysm) Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using either a multibranched stent graft (Off-the-Shelf TAAA Device) or custom-manufactured physician-specified branched and/or fenestrated stent graft (Physician-Specified TAAA Device) to treat aortic aneurysms involving the mesenteric and/or renal arteries (TAAA) in patients at high risk for open surgery.
2. Aortic Arch Study Arm: To assess the feasibility and safety and to evaluate clinical outcomes of endovascular stent graft implantation using 1) physician-specified aortic arch stent graft device with up to 3 antegrade and/or retrograde branches or 2) 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.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darren Schneider, MD; Phone Number: 215-614-0243; Email: darren.schneider@pennmedicine.upenn.edu
• Study Contact Backup: Name: Kiera Zehner; Phone Number: (412) 737-2572; Email: kiera.zehner@pennmedicine.upenn.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Active, not recruiting
      • New York Presbyterian Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Darren Schneider, MD; Phone Number: 215-614-0243; Email: darren.schneider@pennmedicine.upenn.edu
      • Contact: Kiera Zehner; Phone Number: (412) 737-2572; Email: kiera.zehner@pennmedicine.upenn.edu
      • Principal Investigator: Darren Schneider, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

TAAA STUDY ARM

Inclusion Criteria:

1. Presence of TAAA in:

   1. Men with TAAA greater than or equal to 6 cm in diameter
   2. Women with TAAA greater than or equal to 5 cm in diameter
   3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
   4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
   5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
2. Life expectancy more than 2 years
3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol

4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":

   1. Proximal aortic landing zone:

      • ≥ 20mm long
      • ≤ 40mm and ≥ 20mm diameter in parallel aorta
      • free from circumferential thrombus
      • ≤ 60 degrees angulation
   2. Mesenteric/renal aortic diameter ≥ 20mm

   3. Mesenteric arteries:

      • ≥ 10mm long segment of healthy artery for branch attachment
      • Diameter ≥ 4mm and ≤ 12mm
      • Absence of aberrant or early branching, aneurysm or dissection

   4. Renal arteries:

      • ≥ 10mm long segment of healthy artery for branch attachment
      • Diameter ≥ 4mm and ≤ 8mm
      • Absence of aberrant or early branching, aneurysm or dissection

   5. Iliac artery access:

      • ≥ 6mm diameter, and absence of severe calcification and tortuosity
      • Or, planned creation of surgical conduit for TAAA device delivery

   6. For patients with associated common iliac artery aneurysms (>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):

      • ≥ 10mm long segment of healthy internal iliac artery for branch attachment
      • Internal iliac diameter ≥ 5mm and ≤ 12mm
      • External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
      • Minimum common iliac artery luminal diameter ≥ 14mm
      • Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery

5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria):

   1. Age ≥ 65 year

   2. Cardiac disease:

      • CAD (history of MI or angina with positive stress test and not revascularizable)
      • LV Ejection fraction < 40%
      • Symptomatic CHF (NYHC Class II, III, or IV)

   3. Pulmonary disease:

      • Home oxygen therapy
      • FEV1 < 1.2 l/s
      • Vital capacity < 50% predicted
      • PaCO2 > 45 mm Hg or < 60 mm Hg

   4. Renal disease:

      • ESRD on dialysis
      • eGFR < 60
   5. Prior aortic surgery
   6. Hostile abdomen
   7. Portal hypertension (ascites or varices)
   8. Coagulopathy

AORTIC ARCH STUDY ARM

Inclusion Criteria:

1. Presence of aortic arch aneurysm in:

   1. Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or
   2. Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or
   3. Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
   4. Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
   5. Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation
2. Life expectancy more than 2 years
3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.

4. Suitable arterial anatomy for endovascular aortic arch repair with "Aortic Arch Device":

   1. Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass

   2. Proximal aortic landing zone:

      • Native aorta or surgical graft
      • ≥ 20 mm long
      • ≤ 42 mm and ≥ 20 mm diameter in parallel aorta
      • free from circumferential thrombus

   3. Distal aortic landing zone:

      • Native aorta or surgical graft
      • ≥ 20 mm long
      • ≤ 42 mm and ≥ 20 mm diameter in parallel aorta
      • free from circumferential thrombus
      • ≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery

   4. Adequate supra-aortic trunk branch landing zone(s):

      • Innominate artery (if applicable):

        • Native vessel or surgical graft
        • Diameter: 8-22mm
        • Length of sealing zone ≥10mm
        • Acceptable tortuosity
        • Absence of dissection in landing zone

      • Left (or right) common carotid artery (if applicable):

        • Native vessel or surgical graft
        • Diameter 6-16mm
        • Length of sealing zone ≥10mm
        • Acceptable tortuosity
        • Absence of dissection in landing zone

      • Left (or right) subclavian artery (if applicable):

        • Native vessel or surgical graft
        • Diameter: 5-20mm
        • Length of sealing zone ≥10mm
        • Acceptable tortuosity
        • Absence of dissection in landing zone

   5. Iliac artery access:

      • ≥ 6mm diameter, and absence of severe calcification and tortuosity
      • Or, planned creation of surgical conduit for TAAA device delivery

5. Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):

   1. Age > 70 years-old
   2. Prior ascending or aortic arch repair
   3. Multiple (≥2) median sternotomies
   4. Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
   5. Chronic pulmonary disease with FEV1 < 1500ml
   6. Chronic kidney disease with eGFR ≤ 60 ml/kg/hr
   7. Large aneurysm abutting the sternotomy
   8. Severe deconditioning or immobility
   9. Prior cervical irradiation
   10. Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery)

APPLIES TO BOTH STUDY ARMS

Exclusion Criteria:

1. Rupture, with hypotension (systolic bp < 90).
2. Pregnancy or breastfeeding.
3. Unwillingness or inability to comply with the follow up schedule.
4. Serious systemic or groin infection.
5. Uncorrectable coagulopathy.
6. Age < 18 years.
7. Mycotic aneurysm.
8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
10. Participation in another in another investigational device or drug study within 1 year of treatment.
11. 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)
12. Body habitus that would inhibit X-ray visualization of the aorta.
13. Acute aortic dissection
14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAAA (thoracoabdominal aortic aneurysm) Study Arm; 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; 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.
Experimental: Aortic Arch Study Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Freedom from aneurysm-related mortality at 1 year	Survival from aneurysm-related death.	1 year
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
Treatment success at 12 months post-procedure	Composite endpoint which includes Technical Success, Procedural Success, and freedom from aneurysm-related mortality	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target artery patency	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.	Yearly through 5 years
Freedom from all-cause mortality	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from reintervention	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if reintervention with the device is necessary.	Yearly through 5 years
Freedom from endoleak	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.	Yearly through 5 years
Freedom from aneurysm dilatation	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.	Yearly through 5 years
Freedom from serious adverse events (SAE) and major complications	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from aneurysm rupture and conversion to open repair	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation to determine if aneurysm stability.	Yearly through 5 years
Freedom from stent graft migration and branch device migration	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.	Yearly through 5 years
Freedom from major stroke	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from paralysis	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from onset permanent hemodialysis	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from amputation	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from bowel infarction	Clinical evaluations are completed yearly and include bloodwork (WBC, Hemoglobin, Hematocrit, Platelets, BUN [Urea Nitrogen], Creatinine, eGFR), imaging scans (CT scans, Ultrasounds, and/or x-rays) and adverse event evaluation.	Yearly through 5 years
Freedom from loss of target vessel patency	Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.	Yearly through 5 years

Collaborators and Investigators

• Sponsor: Darren Schneider, M.D.
• Investigators: Principal Investigator: Darren Schneider, MD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimated): December 23, 2014

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Aneurysm; Aorta; Endovascular; Thoracoabdominal; Aortic Dissection; Stent-Graft; Aortic Arch; BEVAR; FEVAR
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal; Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic; Dissection, Abdominal Aorta
• Other Study ID Numbers: 843522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No