LIFE Study: Least Invasive Fast-Track EVAR

Study Overview
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Brief Summary
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The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no ICU admission post procedure, and next day discharge.

Detailed Description
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The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the ultra low profile (14F) Ovation Abdominal Stent Graft Platform when using in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of patients with AAA using a Fast-Track EVAR protocol. 250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.

Official Title
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LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Ovation® Abdominal Stent Graft Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years of age. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study). Patient has signed an IRB approved informed consent form. Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following: abdominal aortic aneurysm >5.0 cm in diameter, aneurysm has increased in size by 0.5 cm in last 6 months, or maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. Patient has suitable anatomy that allows use of the TriVascular Ovation® Abdominal Stent Graft Platform. Patient has suitable femoral arteries at the percutaneous access site that allow use of the Perclose ProGlide Suture-Mediated Closure System via the pre-close technique. Patient must be willing to comply with all required follow-up exams. Exclusion Criteria: Patient has a need for emergent surgery. Patient has a dissecting aneurysm. Patient has an acutely ruptured aneurysm. Patient has an acute vascular injury. Patient has had a previous repair of the abdominal aortic aneurysm or the iliac artery. Patient has a mycotic aneurysm or has an active systemic infection. Patient has unstable angina. Patient has unstable peripheral artery disease with critical limb ischemia. Patient has congestive heart failure. Patient has had a myocardial infarction and/or stroke within the past 3 months. Patient requires use of techniques that would cover the renal arteries. Patient requires planned adjunctive devices to complete the procedure. Patient has a major surgical or interventional procedure planned during or within ±30 days of the AAA repair. Patient has history of connective tissue disease. Patient has history of bleeding disorders or refuses blood transfusions. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0mg/dl. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol. Patient is on home oxygen. Patient is morbidly obese (BMI ≥40 kg/m2). Patient was admitted from a skilled nursing facility. Patient has a limited life expectancy of less than 1 year. Patient has an inability to be discharged within 1 day of the procedure. Patient is currently participating in an investigational device or drug clinical trial. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fast-Track Group<br>includes subjects who complete the Fast-Track EVAR protocol | Device: Ovation® Abdominal Stent Graft Platform<br> <br> |
| Standard P-EVAR Group<br>includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access | Device: Ovation® Abdominal Stent Graft Platform<br> <br> |
| Standard EVAR Group<br>includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are not completed with bilateral percutaneous access (i.e. converted to femoral cutdown or open surgical repair) | Device: Ovation® Abdominal Stent Graft Platform<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious and non-serious adverse events, including vascular and major access site vascular complications |  | 30 days | 
| Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access |  | 30 days | 
| Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge |  | 30 days | 
| Blood loss, including if transfusion required |  | 30 days | 
| Percent of procedures completed without general anesthesia |  | 30 days | 
| Anesthesia time |  | 30 days | 
| Procedure time |  | 30 days | 
| Contrast volume |  | 30 days | 
| Fluoroscopy time |  | 30 days | 
| Time to hemostasis |  | 30 days | 
| Time to ambulation |  | 30 days | 
| Time to normal diet |  | 30 days | 
| Groin pain |  | 30 days | 
| Quality of Life |  | 30 days | 
| Percent of subjects discharged without ICU admission |  | 30 days | 
| Length of ICU stay, if required |  | 30 days | 
| Length of hospital stay |  | 30 days | 
| Percent of subjects discharged within only one midnight stay |  | 30 days | 
| Freedom from type I and III endoleaks |  | 30 days | 
| Freedom from AAA rupture |  | 30 days | 
| Freedom from conversion to open repair |  | 30 days | 
| Freedom from AAA related secondary interventions |  | 30 days | 
| Freedom from mortality |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal, aortic, aneurysm