South American Abdominal Stent Graft Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01082185
First received: March 4, 2010
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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).


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082185

Locations
Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
Sponsors and Collaborators
TriVascular, Inc.
  More Information

Additional Information:
No publications provided by TriVascular, Inc.

Additional 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
Study First Received: March 4, 2010
Last Updated: November 25, 2013
Health Authority: Chile: Instituto de Salud Publica de Chile

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

ClinicalTrials.gov processed this record on April 17, 2014