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

NCT ID: NCT06446024

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-07

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: Indigo Aspiration System treatment

Mechanical aspiration thrombectomy

Mechanical aspiration thrombectomy

Intervention Type 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.

Interventions

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Mechanical aspiration thrombectomy

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penumbra Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nara City Hospital

Nara, , Japan

Site Status

Countries

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United States Japan

Other Identifiers

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27548

Identifier Type: -

Identifier Source: org_study_id