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Clinical Trials in Germany / NCT05386277
Recruiting Not applicable

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

NCT05386277 · tracked via the Priya Life Science Germany tracker
Sponsor
LeMaitre Vascular
Phase
Not applicable
Started
2022-01-11
Last updated
2024-10-18

Condition(s) studied

Arterial Thromboembolism

Investigational drug(s) / intervention(s)

TufTex Single Lumen Embolectomy Catheter

TufTex Single Lumen Embolectomy Catheter: The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 arterial or venous emboli and/or thrombi, where one of the LeMaitre® Embolectomy Catheter will 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 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

Primary outcome measure(s)

  • Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure — During procedure and 1 month post index procedure
    The primary safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure and 1 Month post index procedure.
  • Performance objective is the technical success as defined as <30% residual stenosis — 1 month post index procedure
    The primary performance objective is the technical success as defined as \<30% residual stenosis of the target vessel.

Trial sites (3)

FacilityCityRegionStatus
Ziekenhuis Oost-Limburg Genk Belgium Recruiting
Andrej Udelnow Brandenburg Germany Recruiting
Giorgio Prouse Lugano Switzerland Not Yet Recruiting

More LeMaitre Vascular trials in Germany

A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters Recruiting
Prospective and Non-randomized Registry of CardioCel 3D Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05386277 on ClinicalTrials.gov ↗ ← All trials in Germany