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
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
Primary Outcome
The proportion of subjects experiencing a MAE within 30 days post-implantation.
Condition
Abdominal Aortic Aneurysm
Intervention
Endurant Evo AAA Stent Graft System
Study Arms / Comparison Groups
Endovascular repair
Description: 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
Gilbert Upchurch, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02393716
Organization ID
10173341DOC
Responsible Party
Sponsor
Study Sponsor
Medtronic Endovascular
Study Sponsor
Gilbert Upchurch, MD, Principal Investigator, University of Florida
Verification Date
November 2019