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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Arterial Thromboembolism

Intervention / Treatment
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* Device: TufTex Single Lumen Embolectomy Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subject, ≥ 18 years of age at time of enrollment. 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. Subject signed an Informed Consent for participation. Subject diagnosed with a embolus/thrombus. Subjects for whom thrombolytic therapy had failed or was contraindicated. Exclusion Criteria: Co-morbidity that in the discretion of the investigator might confound the results. Subjects who are unable to read or write. Pregnant or lactating women at time of enrollment Subjects who are immune comprised

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LeMaitre TufTex Single Lumen Embolectomy Catheter<br>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<br>* The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi<br>|

What is the study measuring?
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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 |