Endurant Evo International Clinical Trial

Covidien

Status: Terminated

Conditions: AAA; Abdominal Aortic Aneurysm

Treatments: Device: Endurant Evo AAA Stent Graft System; Procedure: Endovascular aneurysm repair (EVAR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02461524

10173339DOC

Details and patient eligibility

About

The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.

Full description

The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm trial.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Magnetic Resonance Angiography (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 bifurcation 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 bifurcation 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

69 participants in 1 patient group

Abdominal Aortic Aneurysm Endovascular repair

Other group

Description:

Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria.

Treatment:

Procedure: Endovascular aneurysm repair (EVAR)

Device: Endurant Evo AAA Stent Graft System