Brief Title
TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair)
Official Title
TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR With the Ovation Prime™ Abdominal Stent Graft System
Brief 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. 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 Type
Observational [Patient Registry]
Primary Outcome
Major Adverse Events
Secondary Outcome
Serious and Non-Serious Adverse Events, including vascular and major access site vascular complications
Condition
Abdominal Aortic Aneurysm
Intervention
Ovation Prime Abdominal Stent Graft System
Study Arms / Comparison Groups
Fast-Track Group
Description: Includes subject who complete the Fast-Track EVAR protocol.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
November 2015
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria:
1. Patient is ≥ 18 years of age.
2. 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).
3. Patient has signed a Research Ethics Board (REB) approved Informed Consent Form.
4. 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).
5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the
following:
- Abdominal aortic aneurysm >5cm in diameter
- 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
6. 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.
7. 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.
8. Patient must be willing to comply with all required follow-up exams.
Exclusion Criteria:
1. Patient has a need for emergent surgery.
2. Patient has a dissecting aneurysm.
3. Patient has an acutely ruptured aneurysm.
4. Patient has an acute vascular injury.
5. Patient has had a previous repair of the abdominal aortic aneurysm or the iliac
artery.
6. Patient has a mycotic aneurysm or has an active systemic infection.
7. 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).
8. Patient has unstable peripheral artery disease with critical limb ischemia (CLI).
9. 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.
10. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 3
months.
11. Patient requires use of techniques (e.g. Chimney graft) that would cover the renal
arteries.
12. Patient requires planned adjunctive devices (e.g. renal stents) to complete the
procedure.
13. Patient has a major surgical or interventional procedure planned during or within ± 30
days of the AAA repair.
14. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos
syndrome).
15. Patient has history of bleeding disorders or refuses blood transfusions.
16. Patient has dialysis dependent renal failure or baseline serum creatinine level
>2.0mg/dl.
17. Patient has a known hypersensitivity or contraindication to anticoagulation or
contrast media that is not amenable to pre-treatment.
18. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-
based polymers, fluorinated ethylene propylene (FEP) or nitinol.
19. Patient is on home oxygen.
20. Patient is morbidly obese (BMI ≥ 40 kg/m2).
21. Patient was admitted from a skilled nursing facility.
22. Patient has a limited life expectancy of less than 1 year.
23. 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.
24. Patient is currently participating in an investigational device or drug clinical
trial.
25. 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Randolph P. Guzman, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02451566
Organization ID
771-0017
Responsible Party
Sponsor
Study Sponsor
TriVascular, Inc.
Study Sponsor
Randolph P. Guzman, MD, Principal Investigator, St. Boniface Hospital
Verification Date
June 2021