Abdominal Aortic AneurysmNCT02224794

LIFE Study: Least Invasive Fast-Track EVAR

An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysm
What is being tested?: Ovation® Abdominal Stent Graft Platform
Type of treatment: Medical device
How many people: 250 participants
Where: 2 sitesUnited States
Study dates: Sep 2014to Jun 2016
How long will I take part?: 1 Month
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Show all 25Show fewer

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 locations and contacts

2 sites in 1 country.

United States2 sites

St. Luke's Episcopal Hospital
Houston, Texas, 77030
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85006

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Abdominal Aortic Aneurysm
Being tested: Ovation® Abdominal Stent Graft Platform
Keywords: abdominal, aortic, aneurysm
Medical subject headings: Aortic Aneurysm, Abdominal, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ovation® Abdominal Stent Graft PlatformDevice

Study groups in NCT02224794
Study group	Role	What they receive
Fast-Track Group		includes subjects who complete the Fast-Track EVAR protocol Receives: 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 Receives: 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) Receives: Device: Ovation® Abdominal Stent Graft Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Events
Measured: 30 days

Secondary outcomes (23)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jun 2016

First posted25 Aug 2014 (estimated)
Study startSep 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 250 participants (actual)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT02224794
Sponsor's protocol ID: 771-0014
Status last verified: Jun 2021
First submitted: 21 Aug 2014
Last updated: 8 Jun 2021
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 29251207
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.
PubMed 26685936

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
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Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
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All Abdominal Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform
ClinicalTrials.gov ID: NCT02224794
Acronym / sponsor ID: 771-0014
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal, aortic, aneurysm
Study type: Observational
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: TriVascular, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2014 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 25 Aug 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Month
Number of arms: 3

Arm	Type	Receives
Fast-Track Group	–	Device: Ovation® Abdominal Stent Graft Platformincludes subjects who complete the Fast-Track EVAR protocol
Standard P-EVAR Group	–	Device: Ovation® Abdominal Stent Graft Platformincludes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access
Standard EVAR Group	–	Device: Ovation® Abdominal Stent Graft Platformincludes 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ovation® Abdominal Stent Graft Platform	Device	Fast-Track Group, Standard EVAR Group, Standard P-EVAR Group

Primary outcome

Major Adverse Events
Time frame: 30 days

23 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
Derived from this study: PubMed 29251207Krajcer 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.
Derived from this study: PubMed 26685936Krajcer 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.
Related InfoLink provided by the sponsor.

Related trials for Abdominal Aortic Aneurysm

Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zvonimir Krajcer, MD principal investigator

CHI St. Luke's Health, Texas

Venkatesh Ramaiah, MD principal investigator

Arizona Heart Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Events (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224794, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.