Clinical Trial

A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II)

Study acronym: STRIDE II
Recruiting
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Summary
The primary objective of this study is to collect and evaluate clinical evidence supporting the safety and performance of the Indigo™ Aspiration System in a patient population with lower extremity acute limb ischemia (LE ALI).
Protocol Amendment History 2 changes
notable Trial sites expanded: 38 -> 42 locations 2026-08-08
notable Trial sites expanded: 28 -> 33 locations 2026-04-28
Trial Details
NCT Number NCT06747117
Lead Sponsor Penumbra Inc.
Conditions Lower Extremity Acute Limb Ischemia, LE ALI
Enrollment 300 participants
Start Date 2025-05-18
Primary Completion 2028-06 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07