Brief Title
TriVascular European Union (EU) Abdominal Stent Graft Trial
Official Title
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation™ 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
A prospective, consecutively enrolling, non-randomized multi center clinical evaluation of
the safety and performance of the TriVascular AAA Stent Graft when used in the treatment of
patients with Abdominal Aortic Aneurysms (AAA).
Study Type
Interventional
Primary Outcome
The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure.
Secondary Outcome
To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure.
Condition
Abdominal Aortic Aneurysm
Intervention
Implant of Ovation Abdominal Stent Graft System
Study Arms / Comparison Groups
Ovation Abdominal Stent Graft System
Description: Implant of Ovation Abdominal Stent Graft System
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
30
Start Date
March 2010
Completion Date
September 16, 2015
Primary Completion Date
October 29, 2010
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 (EC) 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:
- Abdominal aortic aneurysm ≥5.0 cm in diameter
- Aneurysm has increased in size by 0.5 cm 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 patent iliac or femoral arteries that allow endovascular access with the
TriVascular AAA device.
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 suitable non-aneurysmal distal iliac luminal diameters 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 ≤
45º if proximal neck is <10 mm.
13. Patient must be 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 a 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 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 another 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
Thomas Nolte, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01097772
Organization ID
771-0004
Responsible Party
Sponsor
Study Sponsor
TriVascular, Inc.
Study Sponsor
Thomas Nolte, MD, Principal Investigator, Herz- und Gefässzentrum Bad Bevensen
Verification Date
June 2021