What is the LeMaitre4 TufTex Single Lumen Embolectomy Catheter studying for arterial thromboembolism?

The study is assessing the performance and safety of the LeMaitre4 TufTex Single Lumen Embolectomy Catheter in removing arterial emboli and thrombi during surgery. Researchers want to confirm how well the device works and monitor any risks for patients undergoing this procedure. The trial is sponsored by LeMaitre4 Vascular, the device manufacturer.

Who may be eligible for this arterial thromboembolism clinical trial?

Adults aged 18 years or older who have been diagnosed with an embolus or thrombus and are scheduled for surgery to remove it using the LeMaitre4 Embolectomy Catheter may be eligible. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this arterial thromboembolism clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05386277

A Post Market Clinical Study to Confirm the Performance and Safety of the LeMaitre4 TufTex Single Lumen Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli andor Thrombi

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

112

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This clinical trial evaluates the LeMaitre4 TufTex Single Lumen Embolectomy Catheter in patients undergoing surgery to remove arterial emboli and thrombi. The study aims to confirm the devices performance and safety, identify any new risks based on real patient data, and ensure the benefit-risk balance remains acceptable. Sponsored by LeMaitre4 Vascular, Inc., the study is conducted at several sites in Europe with a planned enrollment of 112 patients. Participants will receive treatment using the LeMaitre4 TufTex Single Lumen Embolectomy Catheter, a device featuring a latex balloon attached to a radiopaque shaft. The balloon helps remove emboli and thrombi by being withdrawn through an artery during surgery. This is a single-arm study, meaning all participants receive the device treatment without comparison groups. During the study, researchers will monitor safety outcomes such as device- or procedure-related serious events during and up to one month after the procedure. They will also assess technical success based on the amount of artery narrowing after one month. Additional evaluations include clinical success, revision rates, and artery openness over time. Participants will be followed for at least one month after treatment to track these outcomes and ensure safety.

CONDITIONS

Brief 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

You may qualify if you...

Male and female subjects aged 18 years or older at time of enrollment
Scheduled to undergo surgical treatment for removal of arterial or venous emboli and/or thrombi using a LeMaitre4 Embolectomy Catheter
Signed informed consent for participation
Diagnosed with an embolus or thrombus
Thrombolytic therapy has failed or is contraindicated

You will not qualify if you...

Co-morbid conditions that might affect study results as judged by the investigator
Unable to read or write
Pregnant or lactating women at time of enrollment
Immunocompromised subjects

Research Team

Andrew Hodgkinson

Brian Orrick

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