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The Indigo System in Acute Lower Limb Malperfusion

NCT03386370 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-01-10

No results posted yet for this study

Summary

To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.

Conditions

  • Acute Ischemia of Lower Limb

Interventions

DEVICE

"Indigo" Mechanical Thrombectomy System

Removal of acute clot (\< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Senese

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-03-31
Completion
2019-05-31
FDA Device
Yes

Countries

  • Italy

Study Locations

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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 NCT03386370 on ClinicalTrials.gov