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

N/ACompletedNCT02085551

Penumbra Inc.85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Occlusion or Emboli

Interventions

Mechanical Thrombectomy by the Indigo SystemDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (5)

Tri-City Medical Center

San Diego, California, United States

Baptist Health South Florida

Miami, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Outcomes

Primary Outcomes

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

Proportion of patients with a post-procedure TIMI score of 2 to 3.

Time frame: Immediate post-procedure

Procedural Serious Adverse Events

Time frame: During the procedure

Data from ClinicalTrials.gov

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