LIFE Study: Least Invasive Fast-Track EVAR

Completed

Conditions studied: Abdominal Aortic Aneurysm

In brief

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.

Key facts

Study ID: NCT02224794
Run by: TriVascular, Inc.
People needed: 250
Starts: 2014-09-01
Expected to finish: 2016-06-01
Last updated by the study team: 2021-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States
St. Luke's Episcopal Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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