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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Implantation of a dCell Vascular Patch as part of an Endarterectomy
Szent Imre Hospital
Budapest, Hungary
Miskolc Hospital
Miskolc, Hungary
Semmelweis University Hospital
Semmelweis, Hungary
Saint Elisabeth Hospital
Otrobanda, Curacao, Netherlands
Maintenance of Arterial Patency
Time frame: 6 months for CE Mark, 24 months Post Market Surveillance
Complication Rate
Time frame: 6 months for CE Mark, 24 months for PMS
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