Clinical trial NCT02393716: Endurant Evo US Clinical Trial
Official title: Endurant Evo US Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
AAA
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
timeFrame: 30-days
measure: The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
timeFrame: 12-months
Secondary outcomes:
measure: All-cause Mortality
timeFrame: within 30, 183, and 365 days
measure: Aneurysm-related Mortality (ARM)
timeFrame: within 30, 183, and 365 days
measure: Secondary Procedures to Correct Type I and III Endoleaks
timeFrame: within 183, and 365 days
measure: Secondary Procedures
timeFrame: within 183, and 365 days
measure: Serious Adverse Events
timeFrame: within 30, 183, and 365 days
measure: Conversion to Open Surgery
timeFrame: within 183, and 365 days
measure: Aneurysm Rupture
timeFrame: within 183 and 365 days
measure: Major Adverse Events
timeFrame: within 183 and 365 days
measure: Stent Graft Migration
timeFrame: At 6- and 12-month follow-up visits (as compared to 1-month imaging)
measure: Aneurysm Expansion >5 mm
timeFrame: at 6- and 12-month follow-up visits (as compared to 1-month imaging)
measure: All Endoleaks Based on Imaging Findings
timeFrame: at 1-, 6-, and 12-month follow-up visits
measure: Stent Graft Occlusions Based on Imaging Findings
timeFrame: Through 1-, 6- and 12 months
measure: Device Deficiencies Based on Imaging Findings
timeFrame: Through 6- and 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente Zion Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital & Clinics
state: California
city: Washington
country: United States
facility: Medstar Heart & Vascular Institute
state: District of Columbia
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Sysem
state: Michigan
city: New Hyde Park
country: United States
facility: Long Island Jewish Northshore University Hospital
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg Campus
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Lukes Medial Center
state: Wisconsin
Study officials:
affiliation: University of Florida
name: Gilbert Upchurch, MD
role: PRINCIPAL_INVESTIGATOR
References: