Clinical trial NCT02451566: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal
Aortic
Aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2015-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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.

Primary outcomes:
measure: Major Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Serious and Non-Serious Adverse Events, including vascular and major access site vascular complications
timeFrame: 30 days
measure: Access 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 via Wong-Baker FACES Pain Rating Scale- a 10-point visual analog scale (0=none; 10= worst imaginable)
timeFrame: 30 days
measure: Quality of Life via the EuroQol Group's EQ-5D form
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
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: St. Boniface Hospital
name: Randolph P. Guzman, MD
role: PRINCIPAL_INVESTIGATOR
References: