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A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter

NCT05386277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-10-18

No results posted yet for this study

Summary

A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi

Conditions

  • Arterial Thromboembolism

Interventions

DEVICE

TufTex Single Lumen Embolectomy Catheter

The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • LeMaitre Vascular

    lead INDUSTRY

Principal Investigators

  • Giorgio Prouse · Ospedale Regionale di Lugano - sede Civico

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Switzerland

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 NCT05386277 on ClinicalTrials.gov