A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeMaitre Vascular
About this trial
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subject, ≥ 18 years of age at time of enrollment.
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.
Subject signed an Informed Consent for participation.
Subject diagnosed with a embolus/thrombus.
Disqualifiers
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 compromised
Trial design
Design model
Single group
Treatments tested in this trial
TufTex Over-the-Wire Embolectomy Catheter
DeviceThe 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.
Treatment groups
112 Participants
are divided into 1 treatment groupGroup A: LeMaitre TufTex Over-the-Wire Embolectomy CatheterOther 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
1 month post index procedure2
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.
Time frame
1 month post index procedureSecondary outcomes
1
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
Time frame
1 month post index procedure2
2. Revision rate
Revision rate is defined as the number of patients with target vessel reintervention
Time frame
1 month post index procedure3
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.
Time frame
1 month post index procedure4
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
Time frame
1 month post index procedureOther outcomes
1
Exploratory endpoints
Number of LeMaitre® TufTex OTW Embolectomy Catheters used per intervention
Time frame
1 month post index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
LeMaitre Vascular
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov