Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
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Phase
—
Status
Completed
Study type
Observational
Enrollment
500actual
Sites
1
Country
Japan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-12-07 | actual | When the study began enrolling |
| Primary completion | 2025-07-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-25 | actual | The whole study's end, after follow-up |
| First posted | 2024-06-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Acute Limb Ischemia
- Arterial Occlusion Mesenteric Artery Superior
- Acute DVT of Lower Extremity
Intervention
- Device: Mechanical aspiration thrombectomy
Primary outcomes
what the primary-completion date above is the date OFALI: Target Limb Salvage
measured 30 days post-treatment and 6 months post-treatment
ALI: Technical Success
measured Intraoperative
ALI: Major device-related bleeding in ALI patients
measured Periprocedural
SMA: Technical success
measured Intraoperative
SMA: Device-related Distal Embolization
measured Intraoperative
DVT: Technical success
measured Intraoperative
DVT: Major Device-Related Bleeding
measured Periprocedural
DVT: New Symptomatic Pulmonary Embolism (PE)
measured 30 days post-treatment
DVT: Clinically significant re-thrombosis of the target venous segment
measured 30 days post-treatment
All Disease States: Device-related Serious adverse effects (SAE) and mortality
measured 6 months post-treatment
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