At a glance
ClinicalIndex Comparison Record- ✓Evidence of peripheral or visceral arterial occlusion or embolus with TIMI 0-1 flow prior to treatment
- ✓Treated with components of Penumbra and/or Indigo System
- ✕Concurrent participation in another clinical investigation that may confound results
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery
In Brief
A clinical study evaluating Mechanical Thrombectomy by the Indigo System for Peripheral Arterial Occlusion or Emboli. Completed, enrolled 85 participants across 5 sites.
Detailed Summary
The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. This is a retrospective, single arm, multi-center trial. Up to 100 patients at up to 10 centers will be enrolled. Angiographic assessment of vessel patency at immediate post-procedure as measured by TIMI scores and procedural serious adverse events are assessed and recorded.