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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Peripheral Arterial Occlusion or Emboli

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mechanical thrombectomy by the Indigo System

Group Type EXPERIMENTAL

Mechanical Thrombectomy by the Indigo System

Intervention Type DEVICE

Interventions

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Mechanical Thrombectomy by the Indigo System

Intervention Type DEVICE

Eligibility Criteria

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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.