NCT01776450

Brief Summary

To treat patients with abdominal aortic aneurysms requiring endovascular repair outside of the clinical protocol through compassionate use.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

First QC Date

January 21, 2013

Last Update Submit

July 22, 2019

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm

Interventions

Endovascular AAA repairDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
1. Obtain an independent assessment by an uninvolved physician. 2. Obtain informed consent from the patient or legal representative. The consent form used should provide information pertinent to the patient's specific situation. (If appropriate, the study consent form may be used with an addendum to inform the patient of concerns specific to their situation.) 3. Obtain clearance from the institution in accordance with their policies. 4. Notify the institutional review board and comply with their procedures.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cordis Corporation

Fremont, California, 94555, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Michel S Makaroun, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Takao Ohki, MD

    Jikei University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 28, 2013

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

US(1)