LIFE Study: Least Invasive Fast-Track EVAR

• ClinicalTrials.gov Identifier: NCT02224794
• Recruitment Status: Completed
• First Posted: August 25, 2014
• Last Update Posted: June 8, 2021
• Sponsor: TriVascular, Inc.
• Information provided by (Responsible Party): Endologix ( TriVascular, Inc. )

Tracking Information

• First Submitted Date: August 21, 2014
• First Posted Date: August 25, 2014
• Last Update Posted Date: June 8, 2021
• Actual Study Start Date: September 2014
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 22, 2014): Major Adverse Events [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 22, 2014)

• Serious and non-serious adverse events, including vascular and major access site vascular complications [ Time Frame: 30 days ]
• Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access [ Time Frame: 30 days ]
• Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge [ Time Frame: 30 days ]
• Blood loss, including if transfusion required [ Time Frame: 30 days ]
• Percent of procedures completed without general anesthesia [ Time Frame: 30 days ]
• Anesthesia time [ Time Frame: 30 days ]
• Procedure time [ Time Frame: 30 days ]
• Contrast volume [ Time Frame: 30 days ]
• Fluoroscopy time [ Time Frame: 30 days ]
• Time to hemostasis [ Time Frame: 30 days ]
• Time to ambulation [ Time Frame: 30 days ]
• Time to normal diet [ Time Frame: 30 days ]
• Groin pain [ Time Frame: 30 days ]
• Quality of Life [ Time Frame: 30 days ]
• Percent of subjects discharged without ICU admission [ Time Frame: 30 days ]
• Length of ICU stay, if required [ Time Frame: 30 days ]
• Length of hospital stay [ Time Frame: 30 days ]
• Percent of subjects discharged within only one midnight stay [ Time Frame: 30 days ]
• Freedom from type I and III endoleaks [ Time Frame: 30 days ]
• Freedom from AAA rupture [ Time Frame: 30 days ]
• Freedom from conversion to open repair [ Time Frame: 30 days ]
• Freedom from AAA related secondary interventions [ Time Frame: 30 days ]
• Freedom from mortality [ Time Frame: 30 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LIFE Study: Least Invasive Fast-Track EVAR
• Official Title: LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Month
• Biospecimen: Not Provided
• 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.
• Condition: Abdominal Aortic Aneurysm
• Intervention: Device: Ovation® Abdominal Stent Graft Platform

Study Groups/Cohorts

• Fast-Track Group
  includes subjects who complete the Fast-Track EVAR protocol
  Intervention: 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
  Intervention: 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)
  Intervention: Device: Ovation® Abdominal Stent Graft Platform

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 22, 2014): 250
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02224794
• Other Study ID Numbers: 771-0014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Endologix ( TriVascular, Inc. )
• Original Responsible Party: Same as current
• Current Study Sponsor: TriVascular, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Zvonimir Krajcer, MD; CHI St. Luke's Health, Texas
• Principal Investigator: Venkatesh Ramaiah, MD; Arizona Heart Institute

• PRS Account: Endologix
• Verification Date: June 2021