South American Abdominal Stent Graft Trial

NCT01082185 | Completed Phase 1 DMC

• 1 other identifier: 771-0002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal; aortic; aneurysm; AAA

Outcome Measures

Primary Outcomes (1)

• A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System

  30-Days

Study Arms (1)

Ovation Abdominal Stent Graft System

OTHER

Endovascular implant of Abdominal Aortic Aneurysm Stent Graft

Device: Ovation Abdominal Stent Graft System

Interventions

Ovation Abdominal Stent Graft System DEVICE

Endovascular implant of Abdominal Aortic Aneurysm Stent Graft

Ovation Abdominal Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \> 18 years of age
• 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)
• Patient has signed an Ethics Committee approved Informed Consent Form
• 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.
• Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
• Abdominal aortic aneurysm \>5.0 cm in diameter,
• Aneurysm that 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 normal aortic segment.
• Patient has a patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System.
• Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
• 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.
• Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
• Patient has a suitable non-aneurysmal distal iliac luminal diameter between 8 and 20 mm.
• 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.
• Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥ 10 mm and ≤ 45 if proximal neck is \<10 mm.

You may not qualify if:

• Patient has a dissecting aneurysm.
• Patient has an acutely ruptured aneurysm.
• Patient has an acute vascular injury.
• Patient has need for emergent surgery.
• Patient has a known thoracic aortic aneurysm or dissection.
• Patient has a mycotic aneurysm or has an active systemic infection..
• 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)
• Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
• Patient has a major surgical or interventional procedure planned ≤ 30 days of the AAA repair.
• Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• Patient has history of bleeding disorders or refuses blood transfusions.
• Patient has dialysis dependent renal failure or baseline serum creatinine level \>2.0 mg/dl.
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene-propylene (FEP) or nitinol.
• Patient has a body habitus that would inhibit X-ray visualization of the aorta

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Related Publications (1)

• 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.

  PMID: 23978572 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Francisco Valdes, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 8, 2010
• Study Start: November 1, 2009
• Primary Completion: March 3, 2011
• Study Completion: February 3, 2016
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

CL (1)