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

Arterial Thromboembolism Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386277
• Other study ID #: EC-16-001
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: June 2027

Study information

• Verified date: September 2023
• Source: LeMaitre Vascular
• Contact: Andrew Hodgkinson
• Phone: 781-425-1664
• Email: ahodgkinson[@]lemaitre.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Thromboembolism
• Thromboembolism

Intervention

Device:
• TufTex Single Lumen Embolectomy Catheter
The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Germany	Andrej Udelnow	Brandenburg
Switzerland	Giorgio Prouse	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
LeMaitre Vascular	Avania

Countries where clinical trial is conducted

Belgium,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory endpoints	Number of LeMaitre® Embolectomy Catheters used per intervention Number of balloon tears per intervention.	1 month post index procedure
Primary	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
Primary	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	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
Secondary	2. Revision Rate	Revision rate is defined as the number of patients with target vessel reintervention	1 month post index procedure
Secondary	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
Secondary	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