Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-12 @ 12:48 AM
Study NCT ID:
NCT02224794
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIFE Study: Least Invasive Fast-Track EVAR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Events', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Serious and non-serious adverse events, including vascular and major access site vascular complications', 'timeFrame': '30 days'}, {'measure': 'Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access', 'timeFrame': '30 days'}, {'measure': 'Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge', 'timeFrame': '30 days'}, {'measure': 'Blood loss, including if transfusion required', 'timeFrame': '30 days'}, {'measure': 'Percent of procedures completed without general anesthesia', 'timeFrame': '30 days'}, {'measure': 'Anesthesia time', 'timeFrame': '30 days'}, {'measure': 'Procedure time', 'timeFrame': '30 days'}, {'measure': 'Contrast volume', 'timeFrame': '30 days'}, {'measure': 'Fluoroscopy time', 'timeFrame': '30 days'}, {'measure': 'Time to hemostasis', 'timeFrame': '30 days'}, {'measure': 'Time to ambulation', 'timeFrame': '30 days'}, {'measure': 'Time to normal diet', 'timeFrame': '30 days'}, {'measure': 'Groin pain', 'timeFrame': '30 days'}, {'measure': 'Quality of Life', 'timeFrame': '30 days'}, {'measure': 'Percent of subjects discharged without ICU admission', 'timeFrame': '30 days'}, {'measure': 'Length of ICU stay, if required', 'timeFrame': '30 days'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days'}, {'measure': 'Percent of subjects discharged within only one midnight stay', 'timeFrame': '30 days'}, {'measure': 'Freedom from type I and III endoleaks', 'timeFrame': '30 days'}, {'measure': 'Freedom from AAA rupture', 'timeFrame': '30 days'}, {'measure': 'Freedom from conversion to open repair', 'timeFrame': '30 days'}, {'measure': 'Freedom from AAA related secondary interventions', 'timeFrame': '30 days'}, {'measure': 'Freedom from mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abdominal', 'aortic', 'aneurysm'], 'conditions': ['Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '29251207', 'type': 'DERIVED', 'citation': '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': '26685936', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.endologix.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll male and female subjects 18 years and older that have an AAA and meet all other inclusion/exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is ≥ 18 years of age.\n* 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).\n* Patient has signed an IRB approved informed consent form.\n* Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA.\n* 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.\n* Patient has suitable anatomy that allows use of the TriVascular Ovation® Abdominal Stent Graft Platform.\n* 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.\n* Patient must be willing to comply with all required follow-up exams.\n\nExclusion Criteria:\n\n* Patient has a need for emergent surgery.\n* Patient has a dissecting aneurysm.\n* Patient has an acutely ruptured aneurysm.\n* Patient has an acute vascular injury.\n* Patient has had a previous repair of the abdominal aortic aneurysm or the iliac artery.\n* Patient has a mycotic aneurysm or has an active systemic infection.\n* Patient has unstable angina.\n* Patient has unstable peripheral artery disease with critical limb ischemia.\n* Patient has congestive heart failure.\n* Patient has had a myocardial infarction and/or stroke within the past 3 months.\n* Patient requires use of techniques that would cover the renal arteries.\n* Patient requires planned adjunctive devices to complete the procedure.\n* Patient has a major surgical or interventional procedure planned during or within ±30 days of the AAA repair.\n* Patient has history of connective tissue disease.\n* Patient has history of bleeding disorders or refuses blood transfusions.\n* Patient has dialysis dependent renal failure or baseline serum creatinine level \\>2.0mg/dl.\n* Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.\n* Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.\n* Patient is on home oxygen.\n* Patient is morbidly obese (BMI ≥40 kg/m2).\n* Patient was admitted from a skilled nursing facility.\n* Patient has a limited life expectancy of less than 1 year.\n* Patient has an inability to be discharged within 1 day of the procedure.\n* Patient is currently participating in an investigational device or drug clinical trial.\n* 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.'}, 'identificationModule': {'nctId': 'NCT02224794', 'briefTitle': 'LIFE Study: Least Invasive Fast-Track EVAR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endologix'}, 'officialTitle': 'LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform', 'orgStudyIdInfo': {'id': '771-0014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fast-Track Group', 'description': 'includes subjects who complete the Fast-Track EVAR protocol', 'interventionNames': ['Device: Ovation® Abdominal Stent Graft Platform']}, {'label': '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', 'interventionNames': ['Device: Ovation® Abdominal Stent Graft Platform']}, {'label': '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)', 'interventionNames': ['Device: Ovation® Abdominal Stent Graft Platform']}], 'interventions': [{'name': 'Ovation® Abdominal Stent Graft Platform', 'type': 'DEVICE', 'armGroupLabels': ['Fast-Track Group', 'Standard EVAR Group', 'Standard P-EVAR Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Abrazo Arizona Heart Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Zvonimir Krajcer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHI St. Luke's Health, Texas"}, {'name': 'Venkatesh Ramaiah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriVascular, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}