<qa>  What is the resulting factor in major Tissue loss due to ischemic disease?major Tissue loss due to ischemic disease RutherfordBecker category 6 Serum creatinine level 2.5 mgdl at time of screening visit Known or suspected active infection at the time of the procedure Bleeding diathesis Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol. 