Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

Not Applicable

Recruiting

• Conditions: Type IV Thoracoabdominal Aortic Aneurysms; Juxtarenal Aortic Aneurysms; Suprarenal Aortic Aneurysms

• Registration Number: NCT01937949
• Lead Sponsor: Gustavo Oderich

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-02
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-03
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of subjects who have die at 30 days post treatment	30 days post treatment]	Deaths 30 days after treatment
Number of subjects who experience a Major Adverse Event at 30 days post treatment	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

Name	Time	Method
Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire	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).
Number of Subjects Who Achieve Treatment Success	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.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States