Endurant Evo US Clinical Trial
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Endovascular repair Endurant Evo AAA Stent Graft System |
Device: Endurant Evo AAA Stent Graft System
Procedure: Endovascular aneurysm repair (EVAR)
|
Outcome Measures
Primary Outcome Measures
- The proportion of subjects experiencing a MAE within 30 days post-implantation. [30-days]
- The proportion of subjects with both technical success at the time of index procedure and treatment success at 12-months post-implantation. [12-months]
Secondary Outcome Measures
- All cause-mortality [within 30, 183, and 365 days]
- Aneurysm-related mortality [within 30, 183, and 365 days]
- Secondary procedures to correct Type I and III endoleaks [within 30, 183, and 365 days]
- Secondary procedures [within 30, 183, and 365 days]
- Serious adverse events [within 30, 183, and 365 days]
- Conversion to open surgery [within 30, 183, and 365 days]
- Aneurysm rupture [within 183 and 365 days]
- Major adverse events [within 183 and 365 days]
- Stent graft migration [at 6- and 12-month follow-up visits (as compared to 1-month imaging)]
- Aneurysm expansion >5 mm [at 6- and 12-month follow-up visits (as compared to 1-month imaging)]
- All endoleaks based on imaging findings [at 1-, 6-, and 12-month follow-up visits]
- Stent graft occlusions based on imaging findings [through 1-, 6- and 12 months]
- Device deficiencies based on imaging findings [through 1-, 6- and 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
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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
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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 CT or
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
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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 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 bifur and unilaterally for the AUI
Exclusion Criteria:
-
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
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Subject is pregnant
-
Subject has an aneurysm that is:
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Suprarenal/pararenal/juxtarenal
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Isolated ilio-femoral
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Mycotic
-
Inflammatory
-
Pseudoaneurysm
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Dissecting
-
Ruptured
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Leaking but not ruptured
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Subject requires emergent aneurysm treatment
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Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at the time of screening
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Subject has been previously treated for an abdominal aortic aneurysm
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Subject has a history of bleeding diathesis or coagulopathy
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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
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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
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Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
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Subject has a known allergy or intolerance to the device materials
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Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
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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
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Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
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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
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Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
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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
-
Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
-
Subject has a creatinine level > 2.00 mg/dl (or >176.8 μmol/L)
-
Subject is on dialysis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Zion Medical Center | San Diego | California | United States | 92123 |
| 2 | Stanford Hospital & Clinics | Stanford | California | United States | 94305-5330 |
| 3 | Medstar Heart & Vascular Institute | Washington | District of Columbia | United States | 20010-3017 |
| 4 | Maine Medical Center | Portland | Maine | United States | 04102-3134 |
| 5 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215-5324 |
| 6 | University of Michigan Health Sysem | Ann Arbor | Michigan | United States | 48109 |
| 7 | Long Island Jewish Northshore University Hospital | New Hyde Park | New York | United States | 11040 |
| 8 | The Christ Hospital | Cincinnati | Ohio | United States | 45219-2906 |
| 9 | UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania | United States | 17101-2010 |
| 10 | Erlanger Medical Center | Chattanooga | Tennessee | United States | 37403-2147 |
| 11 | Heart Hospital of Austin | Austin | Texas | United States | 78756-4080 |
| 12 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 13 | Providence Sacred Heart Medical Center | Spokane | Washington | United States | 99204-2307 |
| 14 | Aurora St. Lukes Medial Center | Milwaukee | Wisconsin | United States | 53215-3669 |
Sponsors and Collaborators
- Medtronic Cardiovascular
Investigators
- Principal Investigator: Gilbert Upchurch, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10173341DOC