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South American Abdominal Stent Graft Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01082185
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.

Tracking Information
First Submitted Date  ICMJE March 4, 2010
First Posted Date  ICMJE March 8, 2010
Last Update Posted Date October 18, 2016
Study Start Date  ICMJE November 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2012)
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System [ Time Frame: 30-Days ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2010)
To evaluate the safety of the TriVascular2 Modular Abdominal Stent-Graft System in subjects with Abdominal Aortic Aneurysms. Safety is defined as the absence of device-related serious adverse events within 30-days of endovascular procedure. [ Time Frame: 30-Days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE South American Abdominal Stent Graft Trial
Official Title  ICMJE A Clinical Study to Evaluate the Safety and Performance of the TriVascular Modular Abdominal Stent Graft System
Brief Summary A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Detailed Description This study is a prospective, non-randomized multi-center clinical evaluation of the safety and performance of the TriVascular Modular Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysms (AAA).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Aortic Aneurysm
Intervention  ICMJE Device: Ovation Abdominal Stent Graft System
Endovascular implant of Abdominal Aortic Aneurysm Stent Graft
Study Arms  ICMJE Ovation Abdominal Stent Graft System
Endovascular implant of Abdominal Aortic Aneurysm Stent Graft
Intervention: Device: Ovation Abdominal Stent Graft System
Publications * Mehta M, Valdés FE, Nolte T, Mishkel GJ, Jordan WD, Gray B, Eskandari MK, Botti C; A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System Investigators. One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair. J Vasc Surg. 2014 Jan;59(1):65-73.e1-3. doi: 10.1016/j.jvs.2013.06.065. Epub 2013 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2011)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2010)
10
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 an Ethics Committee 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). ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
  5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:

    1. Abdominal aortic aneurysm >5.0 cm in diameter,
    2. Aneurysm that has increased in size by 0.5 cm in last 6 months,
    3. Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment.
  6. Patient has a patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System.
  7. Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
  8. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
  9. Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
  10. Patient has a suitable non-aneurysmal distal iliac luminal diameter between 8 and 20 mm.
  11. Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm.
  12. Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥ 10 mm and ≤ 45 if proximal neck is <10 mm.
  13. Patient must be able and willing to comply with all required follow-up exams.

Exclusion Criteria:

  1. Patient has a dissecting aneurysm.
  2. Patient has an acutely ruptured aneurysm.
  3. Patient has an acute vascular injury.
  4. Patient has need for emergent surgery.
  5. Patient has a known thoracic aortic aneurysm or dissection.
  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 had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
  9. Patient has a major surgical or interventional procedure planned ≤ 30 days of the AAA repair.
  10. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
  11. Patient has history of bleeding disorders or refuses blood transfusions.
  12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl.
  13. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
  14. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene-propylene (FEP) or nitinol.
  15. Patient has a body habitus that would inhibit X-ray visualization of the aorta
  16. Patient has a limited life expectancy of less than 1 year
  17. Patient is currently participating in an investigational device or drug clinical trial.
  18. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01082185
Other Study ID Numbers  ICMJE 771-0002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TriVascular, Inc.
Study Sponsor  ICMJE TriVascular, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco Valdes, MD Pontificia Universidad Catolica de Chile
PRS Account TriVascular, Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP