A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters

Not Applicable

Recruiting

• Conditions: Embolus; Occlusion; Vessel; Thrombus
• Interventions: Device: TufTex Over-the-Wire Embolectomy Catheter

• Registration Number: NCT05386342
• Lead Sponsor: LeMaitre Vascular

Brief Summary

A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

Detailed Description

This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) 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. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device.

The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc.

The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Study Start: 2023-01-11
• 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 an emboli or thrombi during an embolectomy and/or thrombectomy procedure, 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 compromised

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LeMaitre TufTex Over-the-Wire Embolectomy Catheter	TufTex Over-the-Wire Embolectomy Catheter	The LeMaitre Over the Wire Embolectomy Catherer is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Primary Outcome Measures

Name	Time	Method
Performance objective is the technical success being <30% residual stenosis	1 month post index procedure	The primary performance objective of the study is the technical success as defined as \<30% residual stenosis of the target vessel as evaluated on the completion digital subtraction angiography (DSA).
Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up	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.

Secondary Outcome Measures

Name	Time	Method
1.Clinical success	1 month post 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
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.
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
2. Revision rate	1 month post index procedure	Revision rate is defined as the number of patients with target vessel reintervention

Trial Locations

Locations (3)

Ospedale Regionale di Lugano - sede Civico; 🇨🇭 Lugano, Switzerland

Andrej Udelnow; 🇩🇪 Brandenburg, Germany

University Hospital Carl Gustav Carus TU Dresden; 🇩🇪 Dresden, Germany