Clinical trial NCT02224794: LIFE Study: Least Invasive Fast-Track EVAR
Official title: LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal
aortic
aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll male and female subjects 18 years and older that have an AAA and meet all other inclusion/exclusion criteria.

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 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.

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 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.

Eligibility criteria: 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 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 Criteria:

* 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.

Primary outcomes:
measure: Major Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Serious and non-serious adverse events, including vascular and major access site vascular complications
timeFrame: 30 days
measure: Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access
timeFrame: 30 days
measure: Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge
timeFrame: 30 days
measure: Blood loss, including if transfusion required
timeFrame: 30 days
measure: Percent of procedures completed without general anesthesia
timeFrame: 30 days
measure: Anesthesia time
timeFrame: 30 days
measure: Procedure time
timeFrame: 30 days
measure: Contrast volume
timeFrame: 30 days
measure: Fluoroscopy time
timeFrame: 30 days
measure: Time to hemostasis
timeFrame: 30 days
measure: Time to ambulation
timeFrame: 30 days
measure: Time to normal diet
timeFrame: 30 days
measure: Groin pain
timeFrame: 30 days
measure: Quality of Life
timeFrame: 30 days
measure: Percent of subjects discharged without ICU admission
timeFrame: 30 days
measure: Length of ICU stay, if required
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Percent of subjects discharged within only one midnight stay
timeFrame: 30 days
measure: Freedom from type I and III endoleaks
timeFrame: 30 days
measure: Freedom from AAA rupture
timeFrame: 30 days
measure: Freedom from conversion to open repair
timeFrame: 30 days
measure: Freedom from AAA related secondary interventions
timeFrame: 30 days
measure: Freedom from mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
Study officials:
affiliation: CHI St. Luke's Health, Texas
name: Zvonimir Krajcer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona Heart Institute
name: Venkatesh Ramaiah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.