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Completed

NCT Number: NCT06446024

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Nara City Hospital

Nara, 630-8305, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mechanical aspiration thrombectomy

Device

Mechanical thrombectomy is an endovascular technique for removing blood clots from vessels. Penumbra's Indigo system actively extracts thrombus using a continuous vacuum pump, enabling aspiration of thrombus of various sizes and lengths.

Primary outcomes

  1. ALI: Target Limb Salvage

    Time frame: 30 days post-treatment and 6 months post-treatment

    Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)

  2. ALI: Technical Success

    Time frame: Intraoperative

    Primary technical success should be defined per vessel treated on an intent-to-treat basis and applies only to segment treated with Indigo. Defined as successful use of the device to re-establish any antegrade flow and complete or near complete (95% by volume) removal of thrombus as assessed by visual analysis of angiographic images or by other objective imaging such as DUS, CTA, or MRA.

  3. ALI: Major device-related bleeding in ALI patients

    Time frame: Periprocedural

    Major bleeding events as defined by ISTH

  4. SMA: Technical success

    Time frame: Intraoperative

    Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.

  5. SMA: Device-related Distal Embolization

    Time frame: Intraoperative

    A distal filling defect with an abrupt cut-off, determined to be new since the pre-procedure angiogram, present at the end of the procedure, and clinically significant requiring intervention other than Indigo use. If the area in question was not clearly visualized, filling defects distal to the target lesion cannot be categorized as emboli.

  6. DVT: Technical success

    Time frame: Intraoperative

    Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography

  7. DVT: Major Device-Related Bleeding

    Time frame: Periprocedural

    Major device-related bleeding as defined by ISTH

  8. DVT: New Symptomatic Pulmonary Embolism (PE)

    Time frame: 30 days post-treatment

    Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.

  9. DVT: Clinically significant re-thrombosis of the target venous segment

    Time frame: 30 days post-treatment

    Re-thrombosis of target vein segment requiring re-intervention within 30 days

  10. All Disease States: Device-related Serious adverse effects (SAE) and mortality

    Time frame: 6 months post-treatment

    Device related SAE and all-cause mortality

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Acronym: JapanIndigoPMS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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