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

Penumbra

Status: Completed

Conditions: Peripheral Arterial Occlusion or Emboli

Treatments: Device: Mechanical Thrombectomy by the Indigo System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02085551

CLP 7051

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Mechanical thrombectomy by the Indigo System

Experimental group

Treatment:

Device: Mechanical Thrombectomy by the Indigo System