TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair)

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Safety Study for the Treatment of Abdominal Aortic Aneurysms Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair Sodium Fluoride Imaging of Abdominal Aortic Aneurysms Biomarker Profiling in Abdominal Aortic Aneurysm Patients Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION) Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care ACZ885 for the Treatment of Abdominal Aortic Aneurysm Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT Intact Abdominal Aortic Aneurysm Repair in Portugal The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study

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