The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.
This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group). 150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Implant of Ovation™ Abdominal Stent Graft System
Community Care Physicians
Latham, New York, United States
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
Major adverse events (MAE) are defined as any one of the following events: * Death * Myocardial Infarction * Stroke (excludes TIA) * Renal Failure (excludes renal insufficiency) * Respiratory Failure (excludes COPD or pulmonary complications) * Paralysis (excludes paraparesis) * Bowel Ischemia * Procedural Blood Loss (≥1,000 cc)
Time frame: 30 days
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.
Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: * Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. * Freedom from Type I \& III endoleaks at 12 months * Freedom from stent graft migration at 12 months * Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months * Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric.
Time frame: 1 year
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