Endurant Evo US Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endurant Evo US Clinical Trial

Conditions
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Abdominal Aortic Aneurysm, AAA

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 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: 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 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: Endovascular 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 |
| --- | --- | --- |
| The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation. | The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: All-cause mortality Bowel ischemia Myocardial infarction Paraplegia Procedural blood loss ≥1000 cc Renal failure Respiratory failure Stroke | 30-days | 
| The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation. | Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: AAA diameter increase, defined as > 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months Aneurysm rupture within 365 days Conversion to surgery within 365 days Stent graft migration resulting in a serious adverse event or requiring seco | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | All-cause mortality (ACM) within 30, 183, 365 days | within 30, 183, and 365 days | 
| Aneurysm-related Mortality (ARM) | Aneurysm-related mortality (ARM) within 30, 183, and 365 days | within 30, 183, and 365 days | 
| Secondary Procedures to Correct Type I and III Endoleaks | Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak. | within 183, and 365 days | 
| Secondary Procedures | Secondary procedures within 183 and 365 days | within 183, and 365 days | 
| Serious Adverse Events | Serious adverse events within 30, 183 and 365 days. | within 30, 183, and 365 days | 
| Conversion to Open Surgery | Conversion to open surgery within 183, and 365 days | within 183, and 365 days | 
| Aneurysm Rupture | Aneurysm rupture within 183 and 365 days | within 183 and 365 days | 
| Major Adverse Events | Major adverse events within 183 and 365 days | within 183 and 365 days | 
| Stent Graft Migration | Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is > 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is > 10 mm or coverage of the internal iliac artery. | At 6- and 12-month follow-up visits (as compared to 1-month imaging) | 
| Aneurysm Expansion >5 mm | Aneurysm expansion >5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging) | at 6- and 12-month follow-up visits (as compared to 1-month imaging) | 
| All Endoleaks Based on Imaging Findings | All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality. | at 1-, 6-, and 12-month follow-up visits | 
| Stent Graft Occlusions Based on Imaging Findings | Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis. | Through 1-, 6- and 12 months | 
| Device Deficiencies Based on Imaging Findings | Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15). | Through 6- and 12 months |