An interventional study of TufTex Single Lumen Embolectomy Catheter in Arterial Thromboembolism, sponsored by LeMaitre Vascular. Recruiting at 3 sites in 3 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 Other
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
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.
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® Single Lumen Embolectomy Catheter is a catheter that consists of a natural latex rubber balloon secured with ligatures to a single lumen radiopaque shaft. When the balloon the emboli and/or thrombi can be removed by withdrawing the catheter tip through the arteriotomy.
Device: TufTex Single Lumen Embolectomy Catheter
The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi
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.
Time frame: During procedure and 1 month post index procedure
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.
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 (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.
Time frame: 1 Month after the 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® Embolectomy Catheters used per intervention Number of balloon tears per intervention.
Time frame: 1 month post index procedure
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Jun 2027, 65 months after the start.
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