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

TriVascular, Inc.1 site in 1 country20 target enrollmentNovember 2009

ConditionsAbdominal Aortic Aneurysm

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Abdominal Aortic Aneurysm
Sponsor: TriVascular, Inc.
Enrollment: 20
Locations: 1
Primary Endpoint: A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

February 3, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TriVascular, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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).