Actively Recruiting
A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) 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 investigation is a prospective, single-arm, multicenter post-market study designed to collect clinical data on the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheters. The study aims to confirm the device's performance in removing arterial emboli and thrombi, identify any emerging risks based on factual evidence, and ensure the continued acceptability of its benefit-to-risk ratio. The device is used for patients undergoing surgical treatment for emboli or thrombi removal, with the study sponsored by LeMaitre Vascular, Inc. The study involves using the LeMaitre TufTex OTW Embolectomy Catheter, which is intended for removing emboli and thrombi during embolectomy or thrombectomy. The catheter can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration. The investigation is planned to enroll 112 subjects across four sites in about three countries, with an enrollment period lasting 48 months. Each participant will be followed for one month after the procedure. The total study duration is approximately 56 months, including start-up, recruitment, follow-up, and closure phases. Participants will undergo surgical treatment using the catheter, and researchers will assess technical success defined as less than 30% residual stenosis one month after the procedure. Safety will be monitored during the procedure and follow-up. Additional outcomes measured include clinical success, revision rates, and vessel patency at one month post-procedure. The study includes monitoring for any adverse events to ensure safety and performance. Participation involves one month of follow-up after the surgical procedure to evaluate these outcomes.
CONDITIONS
Brief Title
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 years or older at enrollment
- Scheduled for surgical removal of an embolus or thrombus using a LeMaitre 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-morbidities that might affect study results as judged by the investigator
- Unable to read or write
- Pregnant or lactating women at enrollment
- Immune compromised individuals
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 - 1 day
Participants undergo surgical treatment using the LeMaitre TufTex Over-the-Wire Embolectomy Catheter to remove arterial emboli and/or thrombi, followed by immediate post-operative care.
1 visit (in-person) on the day of surgery
Duration - 1 month
Participants are monitored for performance and safety outcomes after the surgery, including technical success and safety objectives.
Approximately 1 follow-up visit within 1 month post-surgery
Trial Site Locations
Total: 3 locations
1
Andrej Udelnow
Brandenburg, Germany
Actively Recruiting
2
University Hospital Carl Gustav Carus TU Dresden
Dresden, Germany
Not Yet Recruiting
3
Ospedale Regionale di Lugano - sede Civico
Lugano, Switzerland
Actively 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
TREATMENT
Number of Arms
1
Frequently Asked Questions
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