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

Not Applicable

Recruiting

• Conditions: Arterial Thromboembolism
• Interventions: Device: TufTex Single Lumen Embolectomy Catheter

• Registration Number: NCT05386277
• Lead Sponsor: LeMaitre Vascular

Brief Summary

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

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 Timeline

• Study Start: 2022-01-11
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LeMaitre TufTex Single Lumen Embolectomy Catheter	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
2. Revision Rate	1 month post index procedure	Revision rate is defined as the number of patients with target vessel reintervention
1. Clinical success	1 Month after the index procedure	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.
4. Secondary Patency	1 month post index procedure	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.
3. Primary Assisted Patency	1 month post index procedure	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.

Trial Locations

Locations (3)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Giorgio Prouse; 🇨🇭 Lugano, Switzerland

Andrej Udelnow; 🇩🇪 Brandenburg, Germany