Clinical trial NCT01937949: Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts
Official title: Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Juxtarenal Aortic Aneurysms
Suprarenal Aortic Aneurysms
Type IV Thoracoabdominal Aortic Aneurysms
Keywords: Aortic aneurysm
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Cook Group Incorporated
First posted: 2013-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects who have die at 30 days post treatment
timeFrame: 30 days post treatment]
measure: Number of subjects who experience a Major Adverse Event at 30 days post treatment
timeFrame: 30 days post treatment
Secondary outcomes:
measure: Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire
timeFrame: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
measure: Number of Subjects Who Achieve Treatment Success
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Gustavo Oderich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chait J, Tenorio ER, Mendes BC, Barbosa Lima GB, Marcondes GB, Wong J, Macedo TA, De Martino RR, Oderich GS. Impact of gap distance between fenestration and aortic wall on target artery instability following fenestrated-branched endovascular aortic repair. J Vasc Surg. 2022 Jul;76(1):79-87.e4. doi: 10.1016/j.jvs.2022.01.135. Epub 2022 Feb 16.
citation: Oderich GS, Tenorio ER, Mendes BC, Lima GBB, Marcondes GB, Saqib N, Hofer J, Wong J, Macedo TA. Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts. Ann Surg. 2021 Sep 1;274(3):491-499. doi: 10.1097/SLA.0000000000004982.
citation: Tenorio ER, Karkkainen JM, Mendes BC, DeMartino RR, Macedo TA, Diderrich A, Hofer J, Oderich GS. Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1489-1502.e6. doi: 10.1016/j.jvs.2019.07.079. Epub 2019 Oct 11.
citation: Karkkainen JM, Sandri GA, Tenorio ER, Macedo TA, Hofer J, Gloviczki P, Cha S, Oderich GS. Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts. J Vasc Surg. 2019 May;69(5):1356-1366.e6. doi: 10.1016/j.jvs.2018.07.060. Epub 2018 Oct 24.