Arterial Thromboembolism Clinical Trial
Official title:
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
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. ;
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