A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm, Abdominal
- Sponsor
- TriVascular, Inc.
- Enrollment
- 161
- Locations
- 1
- Primary Endpoint
- The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Inclusion Criteria
- •All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
- •Patient is \> 18 years of age
- •Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
- •Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form
- •Patient is considered by the treating physician to be a candidate for elective open surgical repair of the abdominal aortic aneurysm (AAA) (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification. ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
- •Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:
- •Abdominal aortic aneurysm ≥5.0 cm in diameter
- •Aneurysm has increased in size by 0.5 cm in last 6 months.
- •Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
Outcomes
Primary Outcomes
The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure.
Time Frame: 30 days
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)
The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success.
Time Frame: 1 year
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.