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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
112
The SLC Embolectomy Catheter is indicated for the removal of arterial emboli and thrombi
Ziekenhuis Oost-Limburg
Genk, Belgium
RECRUITINGAndrej Udelnow
Brandenburg, Germany
RECRUITINGGiorgio Prouse
Lugano, Switzerland
NOT_YET_RECRUITINGSafety 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
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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