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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-Track Group | Includes subject who complete the Fast-Track EVAR protocol. |
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| Standard P-EVAR Group | Includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access. |
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| Standard EVAR Group | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ovation Prime Abdominal Stent Graft System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Serious and Non-Serious Adverse Events, including vascular and major access site vascular complications | 30 days | |
| Access Technical Success, defined as percent of procedures successfully completed with bilateral percutaneous access | 30 days |
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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 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:
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The study will enroll male and female subjects 18 years of age and older that have an AAA and meet all other inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Randolph P. Guzman, MD | St. Boniface Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| 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 via Wong-Baker FACES Pain Rating Scale- a 10-point visual analog scale (0=none; 10= worst imaginable) | 30 days |
| Quality of Life via the EuroQol Group's EQ-5D form | 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 |