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South American Abdominal Stent Graft Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01082185
First Posted: March 8, 2010
Last Update Posted: October 18, 2016
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.
Information provided by (Responsible Party):
TriVascular, Inc.
  Purpose
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System

Condition Intervention Phase
Abdominal Aortic Aneurysm Device: Ovation Abdominal Stent Graft System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Safety and Performance of the TriVascular Modular Abdominal Stent Graft System

Resource links provided by NLM:


Further study details as provided by TriVascular, Inc.:

Primary Outcome Measures:
  • A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System [ Time Frame: 30-Days ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: August 2016
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ovation Abdominal Stent Graft System
Endovascular implant of Abdominal Aortic Aneurysm Stent Graft
Device: Ovation Abdominal Stent Graft System
Endovascular implant of Abdominal Aortic Aneurysm Stent Graft

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082185


Locations
Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
Sponsors and Collaborators
TriVascular, Inc.
Investigators
Principal Investigator: Francisco Valdes, MD Pontificia Universidad Catolica de Chile
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01082185     History of Changes
Other Study ID Numbers: 771-0002
First Submitted: March 4, 2010
First Posted: March 8, 2010
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by TriVascular, Inc.:
abdominal
aortic
aneurysm
AAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases