Endurant Evo US Clinical Trial

Stopped early · Not applicable

Conditions studied: Abdominal Aortic Aneurysm, AAA

In brief

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.

Key facts

Study ID

NCT02393716

Run by

Medtronic Cardiovascular

People needed

139

Starts

2015-04-01

Expected to finish

2021-06-25

Last updated by the study team

2022-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥18 years old
• Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board
• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
• 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
• 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
• 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

You may not qualify if…

• Subject has a life expectancy ≤1 year
• Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
• Subject is pregnant
• Subject has an aneurysm that is:
• Suprarenal/pararenal/juxtarenal
• Isolated ilio-femoral
• Mycotic
• Inflammatory
• Pseudoaneurysm
• Dissecting
• Ruptured
• Leaking but not ruptured
• Subject requires emergent aneurysm treatment
• Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening
• Subject has been previously treated for an abdominal aortic aneurysm
• Subject has a history of bleeding diathesis or coagulopathy
• 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
• 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
• Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
• Subject has a known allergy or intolerance to the device materials
• Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
• 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
• Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
• 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
• Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator

Where it is running

• 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

Full record on ClinicalTrials.gov

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