Status
Conditions
Treatments
About
The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System 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.
Enrollment
Sex
Ages
Volunteers
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 a Research Ethics Board (REB) approved Informed Consent Form.
Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System).
Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
Patient has suitable anatomy that allows use of the TriVascular Ovation/Ovation Prime Abdominal Stent Graft System:
Patient has suitable femoral arteries at the percutaneous access site that allow use of the Perclose ProGlide Suture-Mediated Closure (SMC) System via the pre-close technique, including:
Patient must be willing to comply with all required follow-up exams.
Exclusion criteria
20 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal