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Trial record 2 of 53706 for:    LIFe study

LIFE Study: Least Invasive Fast-Track EVAR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02224794
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Device: Ovation® Abdominal Stent Graft Platform

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Serious and non-serious adverse events, including vascular and major access site vascular complications [ Time Frame: 30 days ]
  2. Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access [ Time Frame: 30 days ]
  3. Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge [ Time Frame: 30 days ]
  4. Blood loss, including if transfusion required [ Time Frame: 30 days ]
  5. Percent of procedures completed without general anesthesia [ Time Frame: 30 days ]
  6. Anesthesia time [ Time Frame: 30 days ]
  7. Procedure time [ Time Frame: 30 days ]
  8. Contrast volume [ Time Frame: 30 days ]
  9. Fluoroscopy time [ Time Frame: 30 days ]
  10. Time to hemostasis [ Time Frame: 30 days ]
  11. Time to ambulation [ Time Frame: 30 days ]
  12. Time to normal diet [ Time Frame: 30 days ]
  13. Groin pain [ Time Frame: 30 days ]
  14. Quality of Life [ Time Frame: 30 days ]
  15. Percent of subjects discharged without ICU admission [ Time Frame: 30 days ]
  16. Length of ICU stay, if required [ Time Frame: 30 days ]
  17. Length of hospital stay [ Time Frame: 30 days ]
  18. Percent of subjects discharged within only one midnight stay [ Time Frame: 30 days ]
  19. Freedom from type I and III endoleaks [ Time Frame: 30 days ]
  20. Freedom from AAA rupture [ Time Frame: 30 days ]
  21. Freedom from conversion to open repair [ Time Frame: 30 days ]
  22. Freedom from AAA related secondary interventions [ Time Frame: 30 days ]
  23. Freedom from mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224794


Locations
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United States, Arizona
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
United States, Texas
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
TriVascular, Inc.
Investigators
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Principal Investigator: Zvonimir Krajcer, MD CHI St. Luke's Health, Texas
Principal Investigator: Venkatesh Ramaiah, MD Arizona Heart Institute

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT02224794    
Other Study ID Numbers: 771-0014
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: October 2016
Keywords provided by TriVascular, Inc.:
abdominal
aortic
aneurysm
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases