MedTrace Logo

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

NCT06747117 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-20

No results posted yet for this study

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).

Conditions

  • Lower Extremity Acute Limb Ischemia
  • LE ALI

Interventions

DEVICE

Indigo Aspiration System

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Clair, MD · Vanderbilt University Medical Center

  • Dierk Scheinert, MD · Universitätsklinik Leipzig

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-18
Primary Completion
2028-06-30
Completion
2029-01-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

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 NCT06747117 on ClinicalTrials.gov