Endurant Evo US Clinical Trial

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Disease Information

Descriptive Information
Brief Title † Endurant Evo US Clinical Trial
Official Title † Endurant Evo US Clinical Trial
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.
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † The proportion of subjects experiencing a MAE within 30 days post-implantation.
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm AAA
Intervention † DeviceEndurant Evo AAA Stent Graft System
Study Arms / Comparison Groups Endovascular repair Endurant Evo AAA Stent Graft System
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 139
Start Date † April 2015
Completion Date March 2021
Primary Completion Date March 2021
Eligibility 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT02393716
Organization ID 10173341DOC
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Medtronic Endovascular
Collaborators ††
Investigators † Principal Investigator: Gilbert Upchurch, MD, University of Virginia Medical Center
Information Provided By
Verification Date January 2017
First Received Date † March 6, 2015
Last Updated Date January 11, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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