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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
  Purpose

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


Condition Intervention Phase
Abdominal Aortic Aneurysms
 Device: Endurant Stent Graft System
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endurant Stent Graft System US Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Endovascular:

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

Secondary Outcome Measures:
  • Treatment success [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 194
Study Start Date: June 2008
Estimated Study Completion Date: November 2016
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endurant Bifurcated arm Device: Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Other Name: Endovascular treatment of Abdominal Aortic Aneurysm
Experimental: Endurant AUI arm Device: Endurant Stent Graft System
Abdominal Aortic Aneurysm Repair
Other Name: Endovascular treatment of Abdominal Aortic Aneurysm

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥ 18 years old.
  2. 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.
  3. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
  4. 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
  5. Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter
  6. Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA
  7. Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft
  8. 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.
  9. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System.

Exclusion Criteria:

  1. Subject has a life expectancy < 1 year
  2. Subject is participating in another investigational drug or device study
  3. Subject requires emergent aneurysm treatment
  4. Subject is a female of childbearing potential in whom pregnancy cannot be excluded.
  5. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
  6. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705718

  Show 28 Study Locations
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Michel S Makaroun, MD Division of Vascular Surgery University of Pittsburgh Medical Center
  More Information

No publications provided

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00705718     History of Changes
Other Study ID Numbers: Medtronic - 089
Study First Received: June 24, 2008
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Endurant Stent Graft System, endovascular treatment, Abdominal Aortic Aneurysms

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

ClinicalTrials.gov processed this record on May 19, 2013