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

Last updated: October 16, 2024
Sponsor: LeMaitre Vascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thromboembolism

Treatment

TufTex Single Lumen Embolectomy Catheter

Clinical Study ID

NCT05386277
EC-16-001
  • Ages > 18
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female subject, ≥ 18 years of age at time of enrollment.

  2. Subject who is scheduled to undergo surgical treatment for the removal of arterialor venous emboli and/or thrombi, where one of the LeMaitre® Embolectomy Catheterwill be used.

  3. Subject signed an Informed Consent for participation.

  4. Subject diagnosed with a embolus/thrombus.

  5. Subjects for whom thrombolytic therapy had failed or was contraindicated.

Exclusion

Exclusion Criteria:

  1. Co-morbidity that in the discretion of the investigator might confound the results.

  2. Subjects who are unable to read or write.

  3. Pregnant or lactating women at time of enrollment

  4. Subjects who are immune comprised

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: TufTex Single Lumen Embolectomy Catheter
Phase:
Study Start date:
January 11, 2022
Estimated Completion Date:
June 30, 2027

Study Description

This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.

Connect with a study center

  • Ziekenhuis Oost-Limburg

    Genk,
    Belgium

    Active - Recruiting

  • Andrej Udelnow

    Brandenburg,
    Germany

    Active - Recruiting

  • Giorgio Prouse

    Lugano,
    Switzerland

    Site Not Available

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