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Juxtarenal Aortic AneurysmsNCT01937949

Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

A study testing Custom-made Zenith® Fenestrated AAA Endovascular Graft: in people with Juxtarenal Aortic Aneurysms and Suprarenal Aortic Aneurysms, run by Gustavo S Oderich 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

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Custom-made Zenith® Fenestrated AAA Endovascular Graft:
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesUnited States
Study dates
Aug 2013to May 2030
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

General Inclusion Criteria

  • A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
  • Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
  • Aneurysm with a history of growth ≥ 0.5 cm per year
  • Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.

General Exclusion Criteria

  • 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
  • Additional medical restrictions as specified in the Clinical Investigation Plan
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

Trial locations and contacts

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

Andrea C Martinez, MS contact

713-798-6835

andrea.martinez@bcm.edu

Ying Huang, MD, PhD contact

832-355-4033

Ying.Huang@bcm.edu

United States2 sites, 1 recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Mariano R Montemayor, MD, MHA, CCRP, (713) 486-5194, Mariano.R.Montemayor@uth.tmc.edu

    Naveed U Saqib, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Active, not recruiting

Other trials in United States

About this study

Official title: Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts

The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.

Read the detailed description

This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.

Being tested
Custom-made Zenith® Fenestrated AAA Endovascular Graft:
Keywords
Aortic aneurysm
Medical subject headings
Aortic Aneurysm

What participants receive

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

  • Custom-made Zenith® Fenestrated AAA Endovascular Graft:Device

    Also called Endovascular stent, Stent-graft

    The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.

Study groups in NCT01937949
Study groupRoleWhat they receive
EndovascularOtherThe study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. Other names: Endovascular stent Stent-graft
Receives: Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:

What is being measured

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

  1. Number of subjects who have die at 30 days post treatment

    Deaths 30 days after treatment

    Measured: 30 days post treatment]

  2. 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.

    Measured: 30 days post treatment

Secondary outcomes (2)

  1. Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire

    Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).

    Measured: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.

  2. Number of Subjects Who Achieve Treatment Success

    Treatment success is defined by a composite end-point, which includes all the following criteria described below:

    • Technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved.
    • Freedom from type I or III endoleak.
    • Freedom from stent-graft migration.
    • Freedom from aneurysm enlargement >5mm
    • Freedom from aneurysm rupture or conversion to open repair.

    Measured: 12 months

Timeline

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

  1. First posted10 Sep 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionMar 2025
  4. Study completionMay 2030 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01937949
Sponsor's protocol ID
H-57286
Status last verified
Jan 2026
First submitted
4 Sep 2013
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39884565

  • Finnesgard EJ, Jones DW, Beck AW, Eagleton MJ, Farber MA, Gasper WJ, Lee WA, Oderich GS, Schneider DB, Sweet MP, Timaran CH, Schanzer A; United States Aortic Research Consortium. Trends and outcomes over time with fenestrated and branched endovascular aortic repair in the United States Aortic Research Consortium. J Vasc Surg. 2025 Jun;81(6):1235-1243. doi: 10.1016/j.jvs.2025.01.213. Epub 2025 Feb 4.

    PubMed 39914755

  • 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.

    PubMed 40054790

  • 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. 2026 Jul 1;284(1):184-193. doi: 10.1097/SLA.0000000000006676. Epub 2025 Feb 18.

    PubMed 39963789

  • 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.

    PubMed 39904414

  • 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.

    PubMed 37313951

  • Ruiter Kanamori L, Tenorio ER, Babocs D, Savadi S, Baghbani 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.

    PubMed 39074740

  • 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. 2026 Jun 1;283(6):1097-1105. doi: 10.1097/SLA.0000000000006594. Epub 2024 Nov 25.

    PubMed 39584778

  • 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.

    PubMed 37956958

  • Mesnard T, Vacirca A, Baghbani 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.

    PubMed 38141739

  • 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.

    PubMed 38614137

  • 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.

    PubMed 38897392

  • 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

  • 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.

    PubMed 35801701

  • Dias-Neto M, Marcondes G, Tenorio ER, Barbosa Lima GB, Baghbani 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.

    PubMed 36343871

Questions about this trial

What is this clinical trial studying?

A study testing Custom-made Zenith® Fenestrated AAA Endovascular Graft: in people with Juxtarenal Aortic Aneurysms and Suprarenal Aortic Aneurysms, run by Gustavo S Oderich 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?

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 20 Jan 2026. 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 Andrea C Martinez, MS (713-798-6835, andrea.martinez@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects who have die at 30 days post treatment (time frame: 30 days post treatment]). The study lists 2 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 NCT01937949, which also lists 37 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 20 Jan 2026.

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