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

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

Non Recruiting
All
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.

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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