Endurant Stent Graft System

This study is currently recruiting participants.

Verified by Medtronic Endovascular, June 2008

Sponsored by:	Medtronic Endovascular
Information provided by:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT00705718

Purpose

To demonstrate safety and effectivness in the treatment of Abdominal Aortic or Aorto-illiac Aneurysms.

Condition	Intervention
Abdominal Aortic Aneurysms	Device: Endurant Stent Graft System

MedlinePlus related topics: Aneurysms

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Endurant Stent Graft System US Clinical Study

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

Secondary Outcome Measures:

Safety and efficacy through 12 months [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental	Device: Endurant Stent Graft System Abdominal Aortic Aneurysm Repair

Eligibility

Criteria

Inclusion Criteria:

Morphology suitable for endovascular repair.
Adequate iliac/femoral access.
Subject is willing to comply with the protocol and undergo follow-up requirements

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705718

Contacts

Contact: Peyton Willert, MPH

707-525-0111

Locations

United States, Pennsylvania
University of Pittsburg Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Medtronic Endovascular

Investigators

Principal Investigator:

Michel S Makaroun, MD

Division of Vascular Surgery University of Pittsburgh Medical Center

More Information

Responsible Party:	Medtronic Vascular ( Peyton Willert, MPH, Director of Endovascular Clinical Research )
Study ID Numbers:	Medtronic - 089
Study First Received:	June 24, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705718
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:

The Endurant Stent Graft System is for the treatment of Abdominal Aortic Aneurysms

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009