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

Thrombus Clinical Trial

— OTW  

Official title:

A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) 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: NCT05386342
• Other study ID #: EC-16-002
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• 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 PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter

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.

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 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

Related Conditions & MeSH terms

• Embolism
• Thrombosis
• Thrombus

Intervention

Device:
• TufTex Over-the-Wire Embolectomy Catheter
The OTW Catheter can be used for the removal of emboli and thrombi. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.

Locations

Country	Name	City	State
Germany	Andrej Udelnow	Brandenburg
Germany	University Hospital Carl Gustav Carus TU Dresden	Dresden
Switzerland	Ospedale Regionale di Lugano - sede Civico	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
LeMaitre Vascular	Avania

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory endpoints	Number of LeMaitre® TufTex OTW Embolectomy Catheters used per intervention	1 month post index procedure
Primary	Performance objective is the technical success being <30% residual stenosis	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).	1 month post index procedure
Primary	Safety objective is defined as acceptable safety outcomes during the procedure and at follow-up	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.	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	1 month post 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