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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05386342
Other study ID # EC-16-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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