Endurant Evo International Clinical Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2021
• Main ID: NCT02461524
• Date of registration: 01/06/2015
• Prospective Registration: No
• Primary sponsor: Medtronic Cardiovascular
• Public title: Endurant Evo International Clinical Trial
• Scientific title: Endurant Evo International Clinical Trial
• Date of first enrolment: May 2015
• Target sample size: 69
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02461524
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Belgium, Denmark, Netherlands, Sweden

Contacts

• Name: Hence Verhagen, MD, PhD
• Affiliation: Erasmus Medical Center

Key inclusion & exclusion 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 (Magnetic Resonance Angiography) 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 Aorto-Uni-Iliac (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
bilaterally 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 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

AAA

Abdominal Aortic Aneurysm

Intervention(s)

Device: Endurant Evo AAA Stent Graft System

Procedure: Endovascular aneurysm repair (EVAR)

Primary Outcome(s)

Primary Safety Endpoint assessed by the proportion of subjects experiencing a MAE within 30-days post-implantation. [Time Frame: 30 days]

Primary Effectiveness Endpoint assessed by the proportion of subjects with technical success at the index procedure. [Time Frame: Index procedure]

Secondary Outcome(s)

Secondary endovascular procedures [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

All endoleaks based on imaging findings [Time Frame: 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month]

Aneurysm-related mortality [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

Device deficiencies based on imaging findings [Time Frame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month]

Aneurysm expansion > 5 mm (as compared to 1-month imaging) [Time Frame: 12-month, 24-month, 36-month, 48-month and 60-month]

Stent graft migration (as compared to 1-month imaging) [Time Frame: 12-month, 24-month, 36-month, 48-month and 60-month]

Conversion to open surgery [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

Serious adverse events [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

All cause-mortality [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

Aneurysm rupture [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

Secondary procedures to correct Type I and III endoleaks [Time Frame: within 30, 183, and 365 days, then annually until 5-Year post-implantation]

Stent graft occlusion based on imaging findings [Time Frame: Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month]

Major adverse events [Time Frame: within 183, and 365 days, then annually until 5-Year post-implantation]

Secondary ID(s)

10173339DOC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors