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

NCT06446024 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-02-04

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2025-07-25
Completion
2025-07-25
FDA Device
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446024 on ClinicalTrials.gov