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Clinical Trials in Germany / NCT05386342
Recruiting Not applicable

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

NCT05386342 · tracked via the Priya Life Science Germany tracker
Sponsor
LeMaitre Vascular
Phase
Not applicable
Started
2023-01-11
Last updated
2024-10-18

Condition(s) studied

ThrombusEmbolusOcclusion; Vessel

Investigational drug(s) / intervention(s)

TufTex Over-the-Wire Embolectomy Catheter

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.

Study summary

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

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 an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised

Primary outcome measure(s)

  • Performance objective is the technical success being <30% residual stenosis — 1 month post index procedure
    The primary performance objective of the study is the technical success as defined as \<30% residual stenosis of the target vessel as evaluated on the completion digital subtraction angiography (DSA).
  • Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up — 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.

Trial sites (3)

FacilityCityRegionStatus
Andrej Udelnow Brandenburg Germany Recruiting
University Hospital Carl Gustav Carus TU Dresden Dresden Germany Not Yet Recruiting
Ospedale Regionale di Lugano - sede Civico Lugano Switzerland Recruiting

More LeMaitre Vascular trials in Germany

A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter 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 NCT05386342 on ClinicalTrials.gov ↗ ← All trials in Germany