TWO MAIN AREAS MUST BE STUDIED TO DEVELOP A SUITABLE SMALL DIAMETER VASCULAR GRAFT: IMPROVEMENT IN MATERIAL BLOOD COMPATIBILITY AND DEVELOPMENT OF A COMPLIANT GRAFT WHICH MATCHES THAT OF THE NATURAL VESSEL.

TWO MAIN AREAS MUST BE STUDIED TO DEVELOP A SUITABLE SMALL DIAMETER VASCULAR GRAFT: IMPROVEMENT IN MATERIAL BLOOD COMPATIBILITY AND DEVELOPMENT OF A COMPLIANT GRAFT WHICH MATCHES THAT OF THE NATURAL VESSEL. THIS PHASE I SBIR PROPOSAL WILL ONLY ADDRESS THE BLOOD COMPATIBILITY QUESTION AND WILL COMPARE A POLYMER COATED WOVEN DACRON GRAFT AGAINST CONTROL GRAFT MATERIALS OF UNCOATED DACRON AND EXPANDED POLYTETRAFLUOROETHYLENE (E-PTFE). THIS POLYMER COATING HAS BEEN SHOWN TO EXHIBIT GOOD BLOOD COMPATIBILITY FROM PRELIMINARY IN VITRO STUDIES. GRAFT DIAMETERS OF 4 MM WILL BE STUDIED IN VIVO USING DOGS AS THE EXPERIMENTAL ANIMAL MODEL. SIX ANIMALS WILL BE TESTED USING A TOTAL OF 24 GRAFTS (4 PER ANIMAL). BEFORE IMPLANTATION, ALL MATERIALS WILL BE WELL CHARACTERIZED BOTH FOR BULK AND SURFACE PROPERTIES. THE PATENCY OF THE GRAFTS WILL BE CHECKED DAILY BY PALPITATION AND BY TRANSCUTANEOUS APPLICATION OF A DOPPLER FLOWMETER. AFTER EIGHT WEEKS, THE GRAFTS WILL BE RETRIEVED AND ANALYZED USING A WELL DEFINED PROTOCOL. IF THE COATED GRAFTS PROVE SUPERIOR TO THE CONTROL GRAFTS, PHASE II STUDIES WILL ADDRESS THIS COATING PROCESS OVER A SUBSTRATE WHICH MATCHES THE COMPLIANCE OF THE NATURAL VESSEL.