The Boston Scientific ENOVUS Trial
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).
Abdominal Aortic Aneurysm
Device: Boston Scientific ENOVUS AAA Endograft
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety will compare the major morbidity rate in Treatment Group against rate in Control Group within 30 days of the initial procedure.
- Efficacy will evaluate patients (Treatment Group) free from AAA rupture and surgical conversion within 1 year of the initial procedure.
- Safety: AAA related mortality at 30 days & 1 year, Treatment to Control Arm.
- Efficacy: Technical success, AAA enlargement, migration, endoleak, device integrity, in Treatment Arm.
- Clinical Utility: blood loss, procedure/ICU/ anesthesia/hospitalization duration, Treatment to Control Arm.
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.
|Principal Investigator:||Rodney A. White, MD; Chief, Vascular Surgery||University of California, Los Angeles|
|Principal Investigator:||W. Anthony Lee, MD; Assistant Professor of Surgery||University of Florida|