LIFE Study: Least Invasive Fast-Track EVAR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fast-Track Group

includes subjects who complete the Fast-Track EVAR protocol

Ovation® Abdominal Stent Graft Platform

Intervention Type DEVICE

Standard P-EVAR Group

includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access

Ovation® Abdominal Stent Graft Platform

Intervention Type DEVICE

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)

Ovation® Abdominal Stent Graft Platform

Intervention Type DEVICE

Interventions

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Ovation® Abdominal Stent Graft Platform

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No