NCT02085551

Case Review of the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

The Prism Trial: A Retrospective Case Review of Technical Success Using the Penumbra and Indigo Systems for Mechanical Thrombectomy in the Periphery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Penumbra Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Occlusion or Emboli

Interventions

Type	Name	Description
DEVICE	Mechanical Thrombectomy by the Indigo System

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-03-13
• Last updated: 2020-06-22
• Results posted: 2020-06-22

Locations

5 sites across 1 country: United States