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

TriVascular, Inc.7 sites in 1 country30 target enrollmentMarch 2010

ConditionsAbdominal Aortic Aneurysm

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Abdominal Aortic Aneurysm
Sponsor: TriVascular, Inc.
Enrollment: 30
Locations: 7
Primary Endpoint: The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure.
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

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).

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

September 16, 2015

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 (EC) 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 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
•Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular AAA device.
•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 a 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).

Outcomes

Primary Outcomes

The primary safety endpoint is defined as the proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure.

Time Frame: 30-Days

The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure.