LIFE Study: Least Invasive Fast-Track EVAR

NCT02224794 | Completed

• 1 other identifier: 771-0014
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal; aortic; aneurysm

Outcome Measures

Primary Outcomes (1)

• Major Adverse Events

  30 days

Secondary Outcomes (23)

• 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

Study Arms (3)

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

Interventions

Ovation® Abdominal Stent Graft Platform DEVICE

Fast-Track Group; Standard EVAR Group; Standard P-EVAR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (2)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85006, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 29251207 DERIVED

• 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.

  PMID: 26685936 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Zvonimir Krajcer, MD

  CHI St. Luke's Health, Texas

  PRINCIPAL INVESTIGATOR

• Venkatesh Ramaiah, MD

  Arizona Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

US (2)