Abdominal Aortic Aneurysm
Conditions
Keywords
abdominal, aortic, aneurysm
Brief summary
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
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.
Interventions
DEVICEOvation® Abdominal Stent Graft Platform
Sponsors
TriVascular, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Events | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Anesthesia time | 30 days |
| 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 |
| 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 |
| Percent of procedures completed without general anesthesia | 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 |
| Groin pain | 30 days |
Countries
United States
Outcome results
None listed