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Endurant Evo US Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02393716
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm AAA Device: Endurant Evo AAA Stent Graft System Procedure: Endovascular aneurysm repair (EVAR) Not Applicable

Detailed Description:
The clinical evidence collected as part of this trial will be used in conjunction with data collected during the concurrently enrolling Endurant Evo International Clinical Trial.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endurant Evo US Clinical Trial
Study Start Date : April 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Endovascular repair
Endurant Evo AAA Stent Graft System
Device: Endurant Evo AAA Stent Graft System
Procedure: Endovascular aneurysm repair (EVAR)



Primary Outcome Measures :
  1. The proportion of subjects experiencing a MAE within 30 days post-implantation. [ Time Frame: 30-days ]
    Primary Safety endpoint

  2. The proportion of subjects with both technical success at the time of index procedure and treatment success at 12-months post-implantation. [ Time Frame: 12-months ]
    Primary effectiveness endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥18 years old
  2. Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
  3. Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
  4. Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
  5. Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:

    • Aneurysm is >5 cm in diameter (diameter measured is perpendicular to the line of flow)
    • Aneurysm is 4 - 5 cm in diameter and has increased in size ≥0.5 cm within the previous 6 months
  6. Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced CT or

MRA imaging:

  • Proximal neck length of ≥ 10 mm with ≤ 60° infrarenal and ≤ 45° suprarenal neck angulation or Proximal neck length of ≥ 15 mm with ≤ 75° infrarenal and ≤ 60° suprarenal neck angulation
  • Subject has vascular dimensions, e.g., aortic and iliac diameters, lengths from renal arteries to iliac bifurcation and hypogastric arteries, in the range of sizes available for the Endurant Evo AAA stent graft system (measured intima to intima) and within the sizing recommendations (refer to Endurant Evo AAA stent graft system Instructions for Use (IFU))
  • Subject has a proximal aortic neck diameter ≥ 18 mm and ≤ 32 mm
  • The distal fixation center of the iliac arteries must have a diameter ≥ 7 mm and ≤ 25 mm bilaterally for the bifur and unilaterally for the AUI
  • Subject has documented imaging evidence of at least one patent iliac and one femoral artery, or can tolerate a vascular conduit that allows introduction of the Endurant Evo AAA stent graft system
  • Subject has distal non-aneurysmal iliac (cylindrical) fixation length ≥20 mm bilateral for the bifur and unilaterally for the AUI

Exclusion Criteria:

  1. Subject has a life expectancy ≤1 year
  2. Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
  3. Subject is pregnant
  4. Subject has an aneurysm that is:

    • Suprarenal/pararenal/juxtarenal
    • Isolated ilio-femoral
    • Mycotic
    • Inflammatory
    • Pseudoaneurysm
    • Dissecting
    • Ruptured
    • Leaking but not ruptured
  5. Subject requires emergent aneurysm treatment
  6. Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening
  7. Subject has been previously treated for an abdominal aortic aneurysm
  8. Subject has a history of bleeding diathesis or coagulopathy
  9. Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft
  10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft
  11. Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
  12. Subject has a known allergy or intolerance to the device materials
  13. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
  14. Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator
  15. Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
  16. Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA stent graft delivery system (13F-17F) due to vessel size, calcification, or tortuosity
  17. Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
  18. Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion
  19. Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
  20. Subject has a creatinine level > 2.00 mg/dl (or >176.8 μmol/L)
  21. Subject is on dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393716


Locations
United States, California
San Diego Medical Center
San Diego, California, United States
Stanford Hospital & Clinics
Stanford, California, United States
United States, District of Columbia
Medstar Heart & Vascular Institute
Washington, District of Columbia, United States
United States, Maine
Maine Medical Center
Portland, Maine, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
United States, Michigan
University of Michigan Health Sysem
Ann Arbor, Michigan, United States
United States, New York
Long Island Jewish Northshore University Hospital
New Hyde Park, New York, United States
United States, Ohio
The Chirst Hospital
Cincinnati, Ohio, United States
United States, Pennsylvania
Harrisburg Hospital
Harrisburg, Pennsylvania, United States
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States
United States, Texas
Heart Hospital of Austin
Austin, Texas, United States
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Providence Sacred Heart Medical Center
Spokane, Washington, United States
United States, Wisconsin
Aurora St. Lukes Medial Center
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Principal Investigator: Gilbert Upchurch, MD University of Florida

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02393716     History of Changes
Other Study ID Numbers: 10173341DOC
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018

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