Actively Recruiting
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 and/or Thrombi
Led by LeMaitre Vascular · Updated on 2024-10-18
112
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
L
LeMaitre Vascular
Lead Sponsor
A
Avania
Collaborating Sponsor
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 device's 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 The balloon helps remove emboli and thrombi by being withdrawn through an artery during surgery.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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgical treatment to remove arterial emboli and/or thrombi using the LeMaitre® TufTex Single Lumen Embolectomy Catheter.
1 visit (in-person surgery)
Duration - 1 month after the index procedure
Participants are monitored for safety and performance outcomes, including assessments of device safety and technical success.
Approximately 2 follow-up visits
Trial Site Locations
Total: 3 locations
1
Ziekenhuis Oost-Limburg
Genk, Belgium
Actively Recruiting
2
Andrej Udelnow
Brandenburg, Germany
Actively Recruiting
3
Giorgio Prouse
Lugano, Switzerland
Not Yet Recruiting
Research Team
A
Andrew Hodgkinson
B
Brian Orrick
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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