Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

Study Overview
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Brief Summary
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To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.

Detailed Description
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Prospective, two-arm, non-randomized, multicenter clinical study enrolling subjects treated with the bifurcated stent graft in one arm and subjects treated with the AUI in a second arm.

Official Title
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Endurant Stent Graft System US Clinical Study

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Device: Endurant Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years old. Subject (or Subject's legal representative) understands and voluntarily has signed and dated an Informed Consent document approved by the Sponsor and by the Institutional Review Board. Subject is able and willing to comply with the protocol and undergo follow-up requirements. Subject is a suitable candidate for elective surgical repair of AAA by as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, III, or IV Subject has an abdominal aortic or aortoiliac aneurysm characteristics that meet protocol parameter Subject meets all the protocol anatomical criteria* as demonstrated on contrast-enhanced CT or MRA Subject has vascular dimensions in the range of sizes available for the Endurant Stent Graft Subject has documented imaging evidence of at least 1 patent iliac and 1 femoral artery, or can tolerate a vascular conduit that allows introduction of the device. Subject's native vessel anatomy is more suited for the introduction and/ or deployment of an Endurant Uni-Iliac Stent Graft System. Exclusion Criteria: Subject has a life expectancy < 1 year Subject is participating in another investigational drug or device study Subject requires emergent aneurysm treatment Subject is a female of childbearing potential in whom pregnancy cannot be excluded. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment. Subject is morbidly obese (body mass index ≥ 40 kg/m2) or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta.

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endurant Bifurcated arm<br>The Bifurcated arm includes subjects who have received a bifurcated device. The Endurant Stent Graft System Bifurcated device is administered to treat patients with an Abdominal Aortic Aneurysm. | Device: Endurant Stent Graft System<br>* Abdominal Aortic Aneurysm Repair<br>* Other names: Endovascular treatment of Abdominal Aortic Aneurysm;|
| Experimental: Endurant AUI arm<br>The AUI arm includes subjects who have received an AUI device. The Endurant Stent Graft System AUI device is administered to treat patients with an Abdominal Aortic Aneurysm. | Device: Endurant Stent Graft System<br>* Abdominal Aortic Aneurysm Repair<br>* Other names: Endovascular treatment of Abdominal Aortic Aneurysm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure) | The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. All-Cause Mortality Bowel Ischemia Myocardial Infarction Paraplegia Procedural Blood Loss > or equal to 1000 cc Renal Failure Respiratory Failure Stroke | 30 days (Safety) | 
| Major Adverse Events Within 30 Days of Index Procedure | The primary safety endpoint is composite defined as the proportion of subjects free from major adverse events (MAE) within 1 month (day 0 - Day 30)of implant is non-inferior to the proportion of subjects free from MAEs in the Talent Control Group. The endpoint is defined as the proportion of subjects free from occurence of a MAE within 1 month of the implantation of the Endurant Stent Graft. The major adverse events composite endpoint which will be evaluated at 1 month post implant includes the occurrence of any of the following events. All-Cause Mortality Bowel Ischemia Myocardial Infarction Paraplegia Procedural Blood Loss > or equal to 1000 cc Renal Failure Respiratory Failure Stroke | 30 days | 
| Primary Effectiveness Endpoint (Technical Success) | Technical success defined as successful delivery and deployment of the stent graft in the planned location and with no unintentional coverage of both the internal iliac arteries or any visceral aortic branches and with removal of the system. Technical success was assessed intra-operatively. | Intra-operatively | 
| Primary Effectiveness Endpoint (Treatment Success) | Treatment success is defined as Technical success and the following: Freedom from AAA diameter increased, defined as >5 mm increase in maximum diameter as measured on CT scan (or MRA/MRI) at 12 months as compared to 1 month Freedom from Types I and III endoleaks at 12 months including those requiring intervention through 12 months Freedom from aneurysm rupture through 12 months Freedom from conversion to surgery through 12 months Freedom from stent graft migrations resulting in a serious adverse event or requiring secondary intervention through 12 months Freedom from stent graft occlusion at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoints - Safety Evaluation | The following secondary endpoints were included in the Pivotal trial to evaluate the safety profile of the Endurant Stent Graft System. Aneurysm-Related Mortality through 12 months All-Cause Mortality with 30 days All-Cause Mortality within 12 months Major Adverse Events through 12 months Adverse Events through 12 months Unanticipated Adverse Device Events Serious Adverse Events (SAEs) As reported at the time of the data cut off. Device Related Adverse Events Procedure Related Adverse Events Adverse Events (excluding SAEs) | 12 months | 
| Secondary Endpoint - Effectiveness Evaluation | The following secondary endpoints were included in the pivotal trial to evaluate the effectiveness profile of the Endurant Stent Graft System. Stent Graft migration through 12 months Stent Graft Patency through 12 months All stent Graft Endoleaks at 1-month, 6-months, and 12-month Secondary Procedures to correct Type I and type III Endoleaks through 12 months Secondary Endovascular Procedures through 12 months Technical Observations through 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endurant Stent Graft System, Abdominal Aortic Aneurysms, Endovascular Treatment