Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00646048 | A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms | PHASE1 | COMPLETED | 43 | — | — | Feb 1, 2003 | Mar 1, 2010 | Jan 28, 2011 | 7 | United States |
Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.
A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | This arm is for patient that receive the TriVascular Stent-Graft System. |
| Name | Type | Description |
|---|---|---|
| TriVascular Stent-Graft System | DEVICE | TriVascular Stent-Graft System |
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 siz...