Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Endovascular

ClinicalTrials.gov Identifier:

NCT00705718

First received: June 24, 2008

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 24, 2008

Last Updated Date

January 16, 2013

Start Date ^ICMJE

June 2008

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Treatment Success [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00705718 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment success [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Official Title ^ICMJE

Endurant Stent Graft System US Clinical Study

Brief Summary

To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-iliac Aneurysms.

Detailed Description

Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Abdominal Aortic Aneurysms

Intervention ^ICMJE

Device: Endurant Stent Graft System

Abdominal Aortic Aneurysm Repair

Other Name: Endovascular treatment of Abdominal Aortic Aneurysm

Study Arm (s)

Experimental: Endurant Bifurcated arm
Intervention: Device: Endurant Stent Graft System
Experimental: Endurant AUI arm
Intervention: Device: Endurant Stent Graft System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

194

Estimated Completion Date

November 2016

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject is ≥ 18 years old.
Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board.
Subject is able and willing to comply with the protocol and undergo follow-up requirements.
Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV
Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device.
Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

Exclusion Criteria:

Subject has a life expectancy < 1 year
Subject is participating in another investigational drug or device study
Subject requires emergent aneurysm treatment
Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00705718

Other Study ID Numbers ^ICMJE

Medtronic - 089

Has Data Monitoring Committee

Yes

Responsible Party

Medtronic Endovascular

Study Sponsor ^ICMJE

Medtronic Endovascular

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michel S Makaroun, MD

Division of Vascular Surgery University of Pittsburgh Medical Center

Information Provided By

Medtronic Endovascular

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top