Recruiting

Fenestrated Stent Grafts

Sponsor:

Gustavo S Oderich

Code:

NCT01937949

Conditions

Juxtarenal Aortic Aneurysms

Suprarenal Aortic Aneurysms

Type IV Thoracoabdominal Aortic Aneurysms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Custom-made Zenith® Fenestrated AAA Endovascular Graft:

Study Details

Brief 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.

Conditions

Juxtarenal Aortic Aneurysms

Suprarenal Aortic Aneurysms

Type IV Thoracoabdominal Aortic Aneurysms

Study ID

NCT01937949

Start date

Aug, 2013

Status verified date

Jan, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Mar, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Endovascular

The 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

Interventions

Custom-made Zenith® Fenestrated AAA Endovascular 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.

Primary outcome measure

  • Number of subjects who have die at 30 days post treatment [ Time Frame: 30 days post treatment] ]
  • Number of subjects who experience a Major Adverse Event at 30 days post treatment [ Time Frame: 30 days post treatment ]

Central Contacts and Locations

Central contacts

Andrea C Martinez, MS

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

Ying Huang, MD, PhD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Mariano R Montemayor, MD, MHA, CCRP

(713) 486-5194Mariano.R.Montemayor@uth.tmc.edu

Principal Investigator:

Naveed U Saqib, MD

More Information

Sponsor

Gustavo S Oderich

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • Aortic aneurysm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gustavo S Oderich on 2026-01-20.