Endurant Evo US Clinical Trial

NCT ID: NCT02393716

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2021-06-25

Brief Summary

The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (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.

Conditions

Abdominal Aortic Aneurysm; AAA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endovascular repair

Endurant Evo AAA Stent Graft System

Group Type: OTHER

Endurant Evo AAA Stent Graft System

Intervention Type: DEVICE

Endovascular aneurysm repair (EVAR)

Intervention Type: PROCEDURE

Interventions

Endurant Evo AAA Stent Graft System

Intervention Type: DEVICE

Endovascular aneurysm repair (EVAR)

Intervention Type: PROCEDURE

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 computed tomography (CTA) 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 stent graft (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 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilbert Upchurch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Kaiser Permanente Zion Medical Center

San Diego, California, United States

Stanford Hospital & Clinics

Stanford, California, United States

Medstar Heart & Vascular Institute

Washington D.C., District of Columbia, United States

Maine Medical Center

Portland, Maine, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan Health Sysem

Ann Arbor, Michigan, United States

Long Island Jewish Northshore University Hospital

New Hyde Park, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

Heart Hospital of Austin

Austin, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Aurora St. Lukes Medial Center

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

10173341DOC

Identifier Type: -

Identifier Source: org_study_id