South American Abdominal Stent Graft Trial

June 3, 2021 updated by: TriVascular, Inc.

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

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

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Santiago, Chile
        • Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ovation Abdominal Stent Graft System
Endovascular implant of Abdominal Aortic Aneurysm Stent Graft
Endovascular implant of Abdominal Aortic Aneurysm Stent Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Time Frame: 30-Days
30-Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francisco Valdes, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

March 3, 2011

Study Completion (Actual)

February 3, 2016

Study Registration Dates

First Submitted

March 4, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimate)

March 8, 2010

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abdominal Aortic Aneurysm

Clinical Trials on Ovation Abdominal Stent Graft System

3
Subscribe