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Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Primary Purpose

Juxtarenal Aortic Aneurysms, Suprarenal Aortic Aneurysms, Type IV Thoracoabdominal Aortic Aneurysms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom-made Zenith® Fenestrated AAA Endovascular Graft:
Sponsored by
Gustavo Oderich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juxtarenal Aortic Aneurysms focused on measuring Aortic aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endovascular

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.

Full Information

First Posted
September 4, 2013
Last Updated
October 31, 2022
Sponsor
Gustavo Oderich
Collaborators
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01937949
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2013 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
May 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gustavo Oderich
Collaborators
Cook Group Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juxtarenal Aortic Aneurysms, Suprarenal Aortic Aneurysms, Type IV Thoracoabdominal Aortic Aneurysms
Keywords
Aortic aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Custom-made Zenith® Fenestrated AAA Endovascular Graft:
Other Intervention Name(s)
Endovascular stent, Stent-graft
Intervention Description
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 Information:
Title
Number of subjects who have die at 30 days post treatment
Description
Deaths 30 days after treatment
Time Frame
30 days post treatment]
Title
Number of subjects who experience a Major Adverse Event at 30 days post treatment
Description
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.
Time Frame
30 days post treatment
Secondary Outcome Measure Information:
Title
Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire
Description
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).
Time Frame
baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
Title
Number of Subjects Who Achieve Treatment Success
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aidin Baghbanioskouei, MD
Phone
(713) 486-5361
Email
Aidin.Baghbanioskouei@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Oderich, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aidin Baghbanioskouei, MD
Phone
713-486-5361
Email
Aidin.Baghbanioskouei@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35181519
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.
Results Reference
derived
PubMed Identifier
34132698
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.
Results Reference
derived
PubMed Identifier
31611106
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.
Results Reference
derived
PubMed Identifier
30714570
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.
Results Reference
derived

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Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

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