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

Primary Purpose

Arterial Thromboembolism

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

TufTex Single Lumen Embolectomy Catheter

About this trial

This is an interventional other trial for Arterial Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ziekenhuis Oost-LimburgRecruiting
Andrej UdelnowRecruiting
Giorgio Prouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LeMaitre TufTex Single Lumen Embolectomy Catheter

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

2. Revision Rate

Revision rate is defined as the number of patients with target vessel reintervention

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.

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.

Full Information

NCT ID

NCT05386277

First Posted

May 10, 2022

Last Updated

September 22, 2023

Sponsor

LeMaitre Vascular

Collaborators

Avania

1. Study Identification

Unique Protocol Identification Number

NCT05386277

Brief Title

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

Acronym

SLC

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2022 (Actual)

Primary Completion Date

June 2027 (Anticipated)

Study Completion Date

June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LeMaitre Vascular

Collaborators

Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Thromboembolism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LeMaitre TufTex Single Lumen Embolectomy Catheter

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

TufTex Single Lumen Embolectomy Catheter

Intervention Description

The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

Primary Outcome Measure Information:

Title

Safety objective is defined as acceptable safety outcomes (e.g. (Serious) Device and/or Procedure Related Events) during the procedure

Description

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.

Time Frame

During procedure and 1 month post index procedure

Title

Performance objective is the technical success as defined as <30% residual stenosis

Description

The primary performance objective is the technical success as defined as <30% residual stenosis of the target vessel.

Time Frame

1 month post index procedure

Secondary Outcome Measure Information:

Title

1. Clinical success

Description

Time Frame

1 Month after the index procedure

Title

2. Revision Rate

Description

Revision rate is defined as the number of patients with target vessel reintervention

Time Frame

1 month post index procedure

Title

3. Primary Assisted Patency

Description

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.

Time Frame

1 month post index procedure

Title

4. Secondary Patency

Description

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.

Time Frame

1 month post index procedure

Other Pre-specified Outcome Measures:

Title

Exploratory endpoints

Description

Number of LeMaitre® Embolectomy Catheters used per intervention Number of balloon tears per intervention.

Time Frame

1 month post index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew Hodgkinson

Phone

781-425-1664

ahodgkinson@lemaitre.com

First Name & Middle Initial & Last Name or Official Title & Degree

Brian Orrick

Phone

7814251685

borrick@lemaitre.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giorgio Prouse

Organizational Affiliation

Ospedale Regionale di Lugano - sede Civico

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ziekenhuis Oost-Limburg

City

Genk

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wendy Zwinnen

Facility Name

Andrej Udelnow

City

Brandenburg

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrej Udelnow, MD

Facility Name

Giorgio Prouse

City

Lugano

Country

Switzerland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giorgio Prouse, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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