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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fast-Track Group | includes subjects who complete the Fast-Track EVAR protocol |
| |
| Standard P-EVAR Group | includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access |
| |
| 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® Abdominal Stent Graft Platform | 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 | |
| Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll male and female subjects 18 years and older that have an AAA and meet all other inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Zvonimir Krajcer, MD | CHI St. Luke's Health, Texas | Principal Investigator |
| Venkatesh Ramaiah, MD | Arizona Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abrazo Arizona Heart Hospital | Phoenix | Arizona | 85006 | United States | ||
| St. Luke's Episcopal Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29251207 | Derived | Krajcer Z, Ramaiah VG, Henao EA, Metzger DC, Nelson WK, Moursi MM, Rajasinghe HA, Al-Dallow R, Miller LE; LIFE Registry Investigators. Perioperative Outcomes From the Prospective Multicenter Least Invasive Fast-Track EVAR (LIFE) Registry. J Endovasc Ther. 2018 Feb;25(1):6-13. doi: 10.1177/1526602817747871. Epub 2017 Dec 18. | |
| 26685936 |
| Label | URL |
|---|---|
| Related Info | View source |
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| 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 | 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 |
| Houston |
| Texas |
| 77030 |
| United States |
| Krajcer Z, Ramaiah V, Huetter M. Fast-track endovascular aneurysm repair: rationale and design of the multicenter Least Invasive Fast-Track EVAR (LIFE) registry. BMC Cardiovasc Disord. 2015 Dec 19;15:174. doi: 10.1186/s12872-015-0167-1. |