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

(JapanIndigoPMS Trial)

Recruiting at 1 trial location

Overseen By Mikiharu Morita

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Penumbra Inc.

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Intraoperative

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

Inclusion Criteria

I meet Japan's criteria for severe artery or vein blockages in my limbs or gut.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Immediate treatment using the INDIGO Aspiration System for acute artery or vein occlusion

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

2 visits (in-person)

Treatment Details

Participant Groups

Group I: Group 1: Indigo Aspiration System treatment Experimental Treatment 1 Intervention

Mechanical aspiration thrombectomy

Who Is Running the Clinical Trial?

Penumbra Inc.

Lead Sponsor

Trials

38

Recruited

10,800+