A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2010-03-31

Brief Summary

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This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

This arm is for patient that receive the TriVascular Stent-Graft System.

Group Type EXPERIMENTAL

TriVascular Stent-Graft System

Intervention Type DEVICE

TriVascular Stent-Graft System

Interventions

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TriVascular Stent-Graft System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or infertile female
* Have signed an informed consent form.
* Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
* at least one of the following: Abdominal aortic aneurysm \>= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm.
* Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter.

Exclusion Criteria

* A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
* A need for emergent surgery.
* contraindication to undergoing angiography.
* A Thoracic aortic aneurysm that requires treatment.
* Presence of thrombus or atheroma in proximal aortic neck covering \> 50% of the endoluminal surface.
* Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<7mm.
* Congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated(e.g. angiography or CT) prior to treatment.
* Unstable angina
* Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
* Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.)
* Hypercoagulable state.
* Contraindication for anticoagulation.
* Acute renal failure.
* Active systemic infection.
* less than 18 years of age.
* Life expectancy less than 1 year.
* Current, or anticipated participation within 1 year, in another research study involving an investigational device or new drug (with the exception of participation in the Lifeline Registry of Endovascular Therapy).
* Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No