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A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

NCT05386342 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-10-18

No results posted yet for this study

Summary

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

Conditions

  • Thrombus
  • Embolus
  • Occlusion; Vessel

Interventions

DEVICE

TufTex Over-the-Wire Embolectomy Catheter

The OTW Catheter can be used for the removal of emboli and thrombi. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • LeMaitre Vascular

    lead INDUSTRY

Principal Investigators

  • Giorgio Prouse, MD · Ospedale Regionale di Lugano - sede Civico

  • Andrej Udelnow, MD · University of Brandenburg

  • Sandra Korn, MD · University Hospital Carl Gustav Carus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • 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 NCT05386342 on ClinicalTrials.gov