LIFE Study: Least Invasive Fast-Track EVAR

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224794
• Other study ID #: 771-0014
• Status: Completed
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: June 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Ovation® Abdominal Stent Graft Platform

Locations

Country	Name	City	State
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Abrazo Arizona Heart Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
TriVascular, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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