Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts (IDE#1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01937949
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : March 30, 2017
Cook Group Incorporated
Information provided by (Responsible Party):
Gustavo S. Oderich, Mayo Clinic

Brief Summary:
This study will compare two groups of subjects with complex abdominal aortic aneurysms. It will compare their clinical outcomes and quality of life measures. The group being treated in this study will have their aneurysms repaired by an endovascular approach using Zenith® Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients (historical cohort) whose complex aneurysms were treated by open surgical repair.

Condition or disease Intervention/treatment Phase
Juxtarenal Aortic Aneurysms Suprarenal Aortic Aneurysms Type IV Thoracoabdominal Aortic Aneurysms Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft: Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts.
Study Start Date : August 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment

Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft. Instead of making a large incision in the abdomen,the physician makes two small incisions in the groin. Through these incision the devices are placed into the aorta.

Other names:

Endovascular stent Stent-graft

Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:
The graft will be inserted through arteries in the leg (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.
Other Names:
  • Endovascular stent
  • Stent-graft

Primary Outcome Measures :
  1. Number of Subjects Who Die [ Time Frame: 30 days ]
  2. Number of Subjects Who Experience a Major Adverse Event [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire [ Time Frame: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years. ]
    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).

  2. Number of Subjects Who Achieve Treatment Success [ Time Frame: 12 months ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01937949

Contact: Jean R. Wigham, RN 507-293-3496
Contact: Alisa M Diderrich, RN 507-538-8152

United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jean R. Wigham, RN    507-293-3496   
Contact: Alisa M Diderrich, RN    507-538-8152   
Principal Investigator: Gustavo S Oderich, MD         
Sponsors and Collaborators
Mayo Clinic
Cook Group Incorporated
Principal Investigator: Gustavo Oderich, MD Mayo Clinic

Responsible Party: Gustavo S. Oderich, Investigator/Sponor, Mayo Clinic Identifier: NCT01937949     History of Changes
Other Study ID Numbers: 13-002880
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gustavo S. Oderich, Mayo Clinic:
Aortic aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases