LIFE Study: Least Invasive Fast-Track EVAR

LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Ovation® Abdominal Stent Graft Platform

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.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Abrazo Arizona Heart Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fast-Track Group; includes subjects who complete the Fast-Track EVAR protocol	Device: Ovation® Abdominal Stent Graft Platform
Standard P-EVAR Group; includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access	Device: Ovation® Abdominal Stent Graft Platform
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)	Device: Ovation® Abdominal Stent Graft Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Adverse Events	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	30 days
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
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
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

Collaborators and Investigators

• Sponsor: TriVascular, Inc.
• Investigators: Principal Investigator: Zvonimir Krajcer, MD, CHI St. Luke's Health, Texas

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: aneurysm; aortic; abdominal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 771-0014