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

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

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

Study Overview

• Status: Recruiting
• Conditions: Arterial Thromboembolism
• Intervention / Treatment: Device: TufTex Single Lumen Embolectomy Catheter

Detailed Description

This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Hodgkinson; Phone Number: 781-425-1664; Email: ahodgkinson@lemaitre.com
• Study Contact Backup: Name: Brian Orrick; Phone Number: 7814251685; Email: borrick@lemaitre.com

Study Locations

• Belgium
  • Genk, Belgium
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Wendy Zwinnen
• Germany
  • Brandenburg, Germany
    • Recruiting
    • Andrej Udelnow
    • Contact: Andrej Udelnow, MD
• Switzerland
  • Lugano, Switzerland
    • Not yet recruiting
    • Giorgio Prouse
    • Contact: Giorgio Prouse, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LeMaitre TufTex Single Lumen Embolectomy Catheter; The LeMaitre® Single Lumen Embolectomy Catheter is a catheter that consists of a natural latex rubber balloon secured with ligatures to a single lumen radiopaque shaft. When the balloon the emboli and/or thrombi can be removed by withdrawing the catheter tip through the arteriotomy.	Device: TufTex Single Lumen Embolectomy Catheter; The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Clinical success	Clinical success is target vessel dependent and defined as; (1) The absence of target vessel limb amputation post-intervention in case of limb cloths, and 2. successful dialysis sessions performed post-intervention in case of dialysis shunt revascularization (2) Revision rate is defined as the number of patients with target vessel reintervention (3) Primary assisted patency is defined as target vessel patency; the target vessel is patent but there may have been some intervention required to maintain that patency. (4) Secondary patency is defined as the target vessel patency including target vessel that have been occluded and there has been an intervention to restore patency.	1 Month after the index procedure
2. Revision Rate	Revision rate is defined as the number of patients with target vessel reintervention	1 month post index procedure
3. Primary Assisted Patency	Primary assisted patency is defined as target vessel patency; the target vessel is patent but there may have been some intervention required to maintain that patency.	1 month post index procedure
4. Secondary Patency	Secondary patency is defined as the target vessel patency including target vessel that have been occluded and there has been an intervention to restore patency.	1 month post index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory endpoints	Number of LeMaitre® Embolectomy Catheters used per intervention Number of balloon tears per intervention.	1 month post index procedure

Collaborators and Investigators

• Sponsor: LeMaitre Vascular
• Collaborators: Avania
• Investigators: Principal Investigator: Giorgio Prouse, Ospedale Regionale di Lugano - sede Civico

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: EC-16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes