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

Boston Scientific

Status and phase

Completed

Phase 1

Conditions

Abdominal Aortic Aneurysm

Treatments

Device: TriVascular Stent-Graft System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00646048

S2106

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.