Status:
COMPLETED
LIFE Study: Least Invasive Fast-Track EVAR
Lead Sponsor:
TriVascular, Inc.
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT02224794
Start Date
September 1 2014
End Date
June 1 2016
Last Update
June 8 2021
Active Locations (2)
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1
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
2
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030