Abdominal Aortic AneurysmNCT02451566
TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair)
An observational study of Abdominal Aortic Aneurysm, run by TriVascular, Inc. at 1 site in Canada.
Trial summary
The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive conditions defined in the Fast-Track EVAR protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Ovation Prime Abdominal Stent Graft System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Dec 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 of age 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 a Research Ethics Board (REB) approved Informed Consent Form.
- Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System).
- Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
- Abdominal aortic aneurysm >5cm in diameter
Show all 24Show fewer
- Aneurysm has increased in size by 0.5cm in last 6 months
- Maximum diameter of 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/Ovation Prime Abdominal Stent Graft System:
- Iliac or femoral arteries that allow endovascular access with the TriVascular Ovation/Ovation Prime Abdominal Stent Graft System (14F OD).
- Proximal aortic neck landing zone with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery.
- Proximal aortic neck with a length of at least 7 mm proximal to the aneurysm
- Distal iliac artery landing zone an inner wall diameter of no less than 8 mm and no greater than 20 mm.
- Distal iliac artery landing zone an inner wall diameter of no less than 8 mm and no greater than 20 mm.
- Distance from the most distal renal artery to most superior internal iliac artery measurement is at least 130 mm.
- Patient has suitable femoral arteries at the percutaneous access site that allow use of the Perclose ProGlide Suture-Mediated Closure (SMC) System via the pre-close technique, including:
- ≥5 mm in diameter
- At least 2 cm segment for access, 10 mm above the origin of the profunda femoris branch and 10 mm below the lower margin of the inferior epigastric artery as determined on preoperative contrast-enhanced CT, angiography, or ultrasound.
- No calcification on the anterior wall or circumferential (>50%) calcification on the posterior wall.
- No prior groin incision, hematoma, or significant scarring.
- No prior clip or collagen based vascular closure device placement within 90 days of procedure.
- No prior femoral artery needle puncture within 30 days of procedure.
- No current active localized groin infection, traumatic vascular injury, femoral artery aneurysm, arteriovenous (AV( fistula, or pseudoaneurysm.
- 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 (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina).
- Patient has unstable peripheral artery disease with critical limb ischemia (CLI).
- Patient has congestive heart failure (CHF). Subjects in Class I or II will be allowed to participate in the protocol, subjects in Class III or IV should be excluded. The New York Heart Association NYHA Functional Classification is used as a reference, see Appendix III.
- Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 3 months.
- Patient requires use of techniques (e.g. Chimney graft) that would cover the renal arteries.
- Patient requires planned adjunctive devices (e.g. renal stents) 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 (e.g., Marfan's or Ehler's-Danlos syndrome).
- 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 (one midnight stay) of the procedure. Examples included but are not limited to, comorbid conditions, unable to admit the day of procedure, live too far away from treatment center, or insufficient post-operative family support.
- 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
1 site in 1 country.
About this study
Official title: TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR With the Ovation Prime™ Abdominal Stent Graft System
The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Ovation Prime Abdominal Stent Graft System
- 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 Prime Abdominal Stent Graft SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Fast-Track Group | Includes subject who complete the Fast-Track EVAR protocol. Receives: Device: Ovation Prime Abdominal Stent Graft System | |
| 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 Prime Abdominal Stent Graft System | |
| 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 Prime Abdominal Stent Graft System |
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
Access 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 via Wong-Baker FACES Pain Rating Scale- a 10-point visual analog scale (0=none; 10= worst imaginable)
Measured: 30 days
Quality of Life via the EuroQol Group's EQ-5D form
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.
- First posted22 May 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- TriVascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randolph P. Guzman, MD, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451566
- Sponsor's protocol ID
- 771-0017
- Status last verified
- Jun 2021
- First submitted
- 18 May 2015
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR With the Ovation Prime™ Abdominal Stent Graft System
- ClinicalTrials.gov ID
- NCT02451566
- Acronym / sponsor ID
- 771-0017
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal, Aortic, Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TriVascular, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 May 2015 (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.
The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System 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.
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 Prime Abdominal Stent Graft SystemIncludes subject who complete the Fast-Track EVAR protocol. |
| Standard P-EVAR Group | – | Device: Ovation Prime Abdominal Stent Graft SystemIncludes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access. |
| Standard EVAR Group | – | Device: Ovation Prime Abdominal Stent Graft SystemIncludes 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 of age and older that have an AAA and meet all other inclusion/exclusion criteria.
Key inclusion criteria (24 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 a Research Ethics Board (REB) approved Informed Consent Form.
- Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification; refer to Appendix III: ASA Classification System).
- Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
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 Prime Abdominal Stent Graft System | 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
Access 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 via Wong-Baker FACES Pain Rating Scale- a 10-point visual analog scale (0=none; 10= worst imaginable)
Time frame: 30 days
Quality of Life via the EuroQol Group's EQ-5D form
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 4 Jun 2021.
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
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
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.
Randolph P. Guzman, MD principal investigator
St. Boniface Hospital
1 site 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 1 site in Canada.
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 24 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 4 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 1 site in Canada. 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?
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 4 Jun 2021.