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TriVascular Stent-Graft System · 1 trial · 1 indication
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...
The TriVascular Stent-Graft System is used for the treatment of abdominal aortic aneurysm, a condition involving a bulging or weakened area in the abdominal aorta. It is an investigational device being evaluated in clinical trials to assess its safety in treating this condition.
The TriVascular Stent-Graft System is developed by Boston Scientific Corporation, a company traded on the New York Stock Exchange under the ticker symbol BSX. The device is currently in clinical development for the treatment of abdominal aortic aneurysm.
The TriVascular Stent-Graft System is in Phase 1 clinical development. It is an investigational device and has not been approved by the FDA. A Phase 1 trial evaluating its safety in treating abdominal aortic aneurysms has been completed.
The TriVascular Stent-Graft System has one completed clinical trial, identified as NCT00646048. This Phase 1 study evaluated the safety of the device in the treatment of abdominal aortic aneurysms, enrolling 43 participants in the United States. The trial was uncontrolled and not randomized.
The TriVascular Stent-Graft System is a stent-graft device designed to treat abdominal aortic aneurysms. It is intended to reinforce the weakened area of the aorta, but the specific molecular target or mechanism of action has not been disclosed in the available information.