Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05386277

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

Led by LeMaitre Vascular · Updated on 2024-10-18

112

Participants Needed

3

Research Sites

281 weeks

Total Duration

On this page

Sponsors

L

LeMaitre Vascular

Lead Sponsor

A

Avania

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Scheduled for surgical removal of arterial or venous emboli and/or thrombi using a LeMaitre4 Embolectomy Catheter
  • Signed informed consent to participate
  • Diagnosed with an embolus or thrombus
  • Thrombolytic therapy has failed or is contraindicated
Not Eligible

You will not qualify if you...

  • Presence of co-morbidities that could affect study results as judged by the investigator
  • Unable to read or write
  • Pregnant or breastfeeding at enrollment
  • Immune compromised

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Ziekenhuis Oost-Limburg

Genk, Belgium

Actively Recruiting

2

Andrej Udelnow

Brandenburg, Germany

Actively Recruiting

3

Giorgio Prouse

Lugano, Switzerland

Not Yet Recruiting

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Research Team

A

Andrew Hodgkinson

CONTACT

B

Brian Orrick

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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