Abdominal Aortic Aneurysm Clinical Trial
Official title:
A Phase II Evaluation of the Safety and Efficacy of the Boston Scientific ENOVUS AAA Endograft in the Treatment of Abdominal Aortic Aneurysms
A prospective, actively controlled, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA (Treatment Group) as compared to patients treated with conventional open surgery (Control Group).
The primary objectives of this study are to determine whether the Boston Scientific ENOVUS
AAA Endograft is a safe and effective method of treating AAA's in those patients considered
to be suitable candidates for open surgical repair. The safety of the Boston Scientific
ENOVUS AAA Endograft will be determined by comparing the rate of major morbidity in the
Treatment Group against the rate of major morbidity in the Control Group within 30 days of
the initial procedure. The efficacy of the Boston Scientific ENOVUS AAA Endograft will be
determined by evaluating the proportion of patients in the Treatment Group that are free
from AAA rupture and conversion to open surgical repair within 1 year of the initial
procedure.
The secondary safety endpoints will be compared between the Treatment and Control
Groups:Mortality rates at 30 days and 1 year, AAA related mortality at 30 days and 1 year.
The secondary efficacy endpoints will be evaluated in the Treatment Group only and include:
Technical success, enlargement of AAA, migration, significant endoleak, and loss of device
integrity. Secondary Clinical Utility endpoints will be compared between the Treatment and
Control groups and will include: blood loss, duration of procedure, ICU stay, length of
hospital stay, and duration of anesthesia.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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