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

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.

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Key information

Conditions

Peripheral Arterial Occlusion or Emboli Cardiovascular Diseases Embolism Embolism and Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-City Medical Center, San Diego, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Evidence of a peripheral or visceral arterial occlusion or embolus (TIMI 0-1) prior to treatment.
Treatment with components of the Penumbra and/or Indigo System.

Exclusion criteria

Participation in another clinical investigation that may confound the results of the study.

Treatment and study plan

Mechanical Thrombectomy by the Indigo System

Device

Primary outcomes

Angiographic Assessment of Vessel Patency at Immediate Post-procedure as Measured by TIMI Scores

Time frame: Immediate post-procedure

Proportion of patients with a post-procedure TIMI score of 2 to 3.
Procedural Serious Adverse Events

Time frame: During the procedure

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

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

Acronym: PRISM

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 13, 2014
Registry last updated: Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed