Peripheral Arterial Vascular Occlusion Clinical Trial
Official title:
An Open Arm Pilot Study to Evaluate the Safety and Performance of the dCell Vascular Patch in Reconstructive Peripheral Vascular Surgery
The study is designed to produce early safety and performance data in a small group of
patients requiring repair of a peripheral vascular endarterectomy (incision into an artery
feeding the limbs which requires a patch to repair the incision after removal of an
atherosclerotic plaque that was stopping usual blood flow to the limbs).
Data is being collected to show the procedure is safe and allows for normal blood flow to be
resumed.
Data will be used to facilitate CE Mark submission.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment