Clinical trial NCT01082185: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal
aortic
aneurysm
AAA
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
timeFrame: 30-Days
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Francisco Valdes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta M, Valdes 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.