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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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Peripheral Arterial Vascular Occlusion
dCell Vascular Patch
Szent Imre Hospital
Active, not recruiting
Tissue Regenix Ltd
Published on BioPortfolio: 2014-08-27T03:20:03-0400
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Obstruction of the flow in the SPLANCHNIC CIRCULATION by ATHEROSCLEROSIS; EMBOLISM; THROMBOSIS; STENOSIS; TRAUMA; and compression or intrinsic pressure from adjacent tumors. Rare causes are drugs, intestinal parasites, and vascular immunoinflammatory diseases such as PERIARTERITIS NODOSA and THROMBOANGIITIS OBLITERANS. (From Juergens et al., Peripheral Vascular Diseases, 5th ed, pp295-6)
Obstruction of flow in biological or prosthetic vascular grafts.
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Loss of vascular ELASTICITY due to factors such as AGING; and ARTERIOSCLEROSIS. Increased arterial stiffness is one of the RISK FACTORS for many CARDIOVASCULAR DISEASES.
The vascular resistance to the flow of BLOOD through the CAPILLARIES portions of the peripheral vascular bed.
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