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Group 1: Indigo Aspiration System treatment for Acute Limb Ischemia (JapanIndigoPMS Trial)

N/A
Recruiting
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-treatment
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Acute Limb Ischemia
  • Mesenteric Artery Occlusion
  • Deep Vein Thrombosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ALI: Major device-related bleeding in ALI patients
ALI: Target Limb Salvage
ALI: Technical Success
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Group 1: Indigo Aspiration System treatmentExperimental Treatment1 Intervention
Mechanical aspiration thrombectomy

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Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
9,951 Total Patients Enrolled
~237 spots leftby Aug 2025
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