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Aortic Aneurysm, ThoracoabdominalNCT02323581

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

A study testing Endovascular treatment of Thoracoabdominal Aortic Aneurysm and Endovascular treatment of Aortic Arch Aneurysms in people with Aortic Aneurysm, Thoracoabdominal and Aortic Aneurysm, Thoracic, run by Darren Schneider, M.D. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Endovascular treatment of Thoracoabdominal Aortic Aneurysm and Endovascular treatment of Aortic Arch Aneurysms
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
2 sitesUnited States
Study dates
Nov 2013to Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 106Show fewer
  • 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
  • Mesenteric arteries:
  • ≥ 10mm long segment of healthy artery for branch attachment
  • Diameter ≥ 4mm and ≤ 12mm
  • Absence of aberrant or early branching, aneurysm or dissection
  • Renal arteries:
  • ≥ 10mm long segment of healthy artery for branch attachment
  • Diameter ≥ 4mm and ≤ 8mm
  • Absence of aberrant or early branching, aneurysm or dissection
  • Iliac artery access:
  • ≥ 6mm diameter, and absence of severe calcification and tortuosity
  • Or, planned creation of surgical conduit for TAAA device delivery
  • 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
  • Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
  • Age ≥ 65 year
  • 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)
  • Pulmonary disease:
  • Home oxygen therapy
  • FEV1 < 1.2 l/s
  • Vital capacity < 50% predicted
  • PaCO2 > 45 mm Hg or < 60 mm Hg
  • Renal disease:
  • ESRD on dialysis
  • eGFR < 60
  • Prior aortic surgery
  • Hostile abdomen
  • Portal hypertension (ascites or varices)
  • Coagulopathy
  • AORTIC ARCH STUDY ARM
  • Presence of aortic arch aneurysm in:
  • Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or
  • Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or
  • Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
  • Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm/year, or
  • Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation
  • 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 aortic arch repair with "Aortic Arch Device":
  • Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass
  • 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
  • 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
  • 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
  • Iliac artery access:
  • ≥ 6mm diameter, and absence of severe calcification and tortuosity
  • Or, planned creation of surgical conduit for TAAA device delivery
  • 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):
  • Age > 70 years-old
  • Prior ascending or aortic arch repair
  • Multiple (≥2) median sternotomies
  • Ischemic cardiomyopathy with multi-level coronary artery disease and/or positive stress test
  • Chronic pulmonary disease with FEV1 < 1500ml
  • Chronic kidney disease with eGFR ≤ 60 ml/kg/hr
  • Large aneurysm abutting the sternotomy
  • Severe deconditioning or immobility
  • Prior cervical irradiation
  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Darren Schneider, MD contact

215-614-0243

Darren.Schneider@Pennmedicine.upenn.edu

Kiera Zehner contact

(412) 737-2572

kiera.zehner@pennmedicine.upenn.edu

United States2 sites, 1 recruiting

  • New York Presbyterian Hospital

    New York, New York, 10022

    Active, not recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Darren Schneider, MD, 215-614-0243, darren.schneider@pennmedicine.upenn.edu

    Kiera Zehner, (412) 737-2572, kiera.zehner@pennmedicine.upenn.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Endovascular treatment of Thoracoabdominal Aortic Aneurysm, Endovascular treatment of Aortic Arch Aneurysms
Keywords
Thoracoabdominal, Aneurysm, Endovascular, Stent-Graft, Aortic Arch, BEVAR, FEVAR, Aorta, Aortic Dissection
Medical subject headings
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Thoracic, Dissection, Abdominal Aorta, Aneurysm, Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular treatment of Thoracoabdominal Aortic AneurysmDevice

    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.

  • Endovascular treatment of Aortic Arch AneurysmsDevice

    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.

Study groups in NCT02323581
Study groupRoleWhat they receive
TAAA (thoracoabdominal aortic aneurysm) Study ArmExperimentalEither 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.
Receives: Device: Endovascular treatment of Thoracoabdominal Aortic Aneurysm
Aortic Arch Study ArmExperimentalPhysician-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.
Receives: Device: Endovascular treatment of Aortic Arch Aneurysms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Intraoperative

  2. 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.

    Measured: 30 days

  3. Freedom from aneurysm-related mortality at 1 year

    Survival from aneurysm-related death.

    Measured: 1 year

  4. Treatment success at 12 months post-procedure

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

    Measured: 1 year

Secondary outcomes (14)

  1. Target artery patency

    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate target artery patency.

    Measured: Yearly through 5 years

  2. 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.

    Measured: Yearly through 5 years

  3. 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.

    Measured: Yearly through 5 years

  4. Freedom from endoleak

    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate device integrity and any device leaks.

    Measured: Yearly through 5 years

  5. Freedom from aneurysm dilatation

    Imaging studies (CT Scans, Ultrasound and/or x-rays) are completed yearly to evaluate aneurysm size.

    Measured: Yearly through 5 years

  6. 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.

    Measured: Yearly through 5 years

  7. 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.

    Measured: Yearly through 5 years

  8. 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.

    Measured: Yearly through 5 years

  9. 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.

    Measured: Yearly through 5 years

  10. 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.

    Measured: Yearly through 5 years

  11. 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.

    Measured: Yearly through 5 years

  12. 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.

    Measured: Yearly through 5 years

  13. 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.

    Measured: Yearly through 5 years

  14. 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.

    Measured: Yearly through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02323581
Sponsor's protocol ID
843522
Status last verified
Dec 2025
First submitted
18 Dec 2014
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No

Publications

  • 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.

    PubMed 28527678

  • 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.

    PubMed 28259569

  • 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.

    PubMed 30080733

  • 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.

    PubMed 37395613

  • 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.

    PubMed 37330702

  • 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.

    PubMed 37321524

  • 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.

    PubMed 37059239

  • 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.

    PubMed 37051912

  • 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.

    PubMed 36948277

  • 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.

    PubMed 36921644

  • 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 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.

    PubMed 36731757

  • 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.

    PubMed 36257344

  • 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.

    PubMed 34954272

  • 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.

    PubMed 33775747

  • 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.

    PubMed 33262091

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular treatment of Thoracoabdominal Aortic Aneurysm and Endovascular treatment of Aortic Arch Aneurysms in people with Aortic Aneurysm, Thoracoabdominal and Aortic Aneurysm, Thoracic, run by Darren Schneider, M.D. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 106 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Darren Schneider, MD (215-614-0243, Darren.Schneider@Pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Success (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02323581, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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