Brief Title
South American Abdominal Stent Graft Trial
Official Title
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Condition
Abdominal Aortic Aneurysm
Intervention
Ovation Abdominal Stent Graft System
Study Arms / Comparison Groups
Ovation Abdominal Stent Graft System
Description: Endovascular implant of Abdominal Aortic Aneurysm Stent Graft
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 2009
Completion Date
August 2016
Primary Completion Date
February 2011
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 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Francisco Valdes, MD, ,
Location Countries
Chile
Location Countries
Chile
Administrative Informations
NCT ID
NCT01082185
Organization ID
771-0002
Responsible Party
Sponsor
Study Sponsor
TriVascular, Inc.
Study Sponsor
Francisco Valdes, MD, Principal Investigator, Pontificia Universidad Catolica de Chile
Verification Date
October 2016