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Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan

Recruiting
years of age
Both
Phase N/A

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Overview

This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.

Eligibility

Inclusion Criteria:

        Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower
        limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
        Exclusion Criteria:
        Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute
        lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein
        thrombosis.

Study details

Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity

NCT06446024

Penumbra Inc.

15 June 2024

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