Endurant Evo International Clinical Trial

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

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

Official Title
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Endurant Evo International Clinical Trial

Conditions
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AAA, Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Endurant Evo AAA Stent Graft System
* Procedure: Endovascular aneurysm repair (EVAR)


Participation Criteria
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Eligibility Criteria
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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. 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 CT or MRA (Magnetic Resonance Angiography) 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 bifur 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 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 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 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endovasculair repair<br>Endurant Evo AAA Stent graft system | Device: Endurant Evo AAA Stent Graft System<br> <br> Procedure: Endovascular aneurysm repair (EVAR)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint assessed by the proportion of subjects experiencing a MAE within 30-days post-implantation. |  | 30 days | 
| Primary Effectiveness Endpoint assessed by the proportion of subjects with technical success at the index procedure. |  | Index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause-mortality |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Aneurysm-related mortality |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Secondary procedures to correct Type I and III endoleaks |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Secondary endovascular procedures |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Serious adverse events |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Aneurysm rupture |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Conversion to open surgery |  | within 30, 183, and 365 days, then annually until 5-Year post-implantation | 
| Major adverse events |  | within 183, and 365 days, then annually until 5-Year post-implantation | 
| Stent graft migration (as compared to 1-month imaging) |  | 12-month, 24-month, 36-month, 48-month and 60-month | 
| Aneurysm expansion > 5 mm (as compared to 1-month imaging) |  | 12-month, 24-month, 36-month, 48-month and 60-month | 
| All endoleaks based on imaging findings |  | 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | 
| Stent graft occlusion based on imaging findings |  | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | 
| Device deficiencies based on imaging findings |  | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |