LIFE Study: Least Invasive Fast-Track EVAR

TriVascular

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Ovation® Abdominal Stent Graft Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT02224794

771-0014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

250 participants in 3 patient groups

Fast-Track Group

Description:

includes subjects who complete the Fast-Track EVAR protocol

Treatment:

Device: Ovation® Abdominal Stent Graft Platform

Standard P-EVAR Group

Description:

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

Treatment:

Device: Ovation® Abdominal Stent Graft Platform

Standard EVAR Group

Description:

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)

Treatment:

Device: Ovation® Abdominal Stent Graft Platform