An interventional study of TufTex Over-the-Wire Embolectomy Catheter in Thrombus, Embolus and Occlusion; Vessel, sponsored by LeMaitre Vascular. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by LeMaitre Vascular · Not applicable, Interventional, and Treatment
A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
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.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
This study's planned enrollment of 112 is above the median of 83 across 530 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →LeMaitre Vascular is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The LeMaitre Over the Wire Embolectomy Catherer is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
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.
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 procedure
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 procedure
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 procedure
2. Revision rate
Revision rate is defined as the number of patients with target vessel reintervention
Time frame: 1 month post index procedure
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 procedure
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 procedure
Exploratory endpoints
Number of LeMaitre® TufTex OTW Embolectomy Catheters used per intervention
Time frame: 1 month post index procedure
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