Arterial Closure Device Comparison Trial II – ACDC Trial II

• A composite of major vascular complications defined as device failure, bleeding, large hematoma, local infection etc.
  

• Time to hemostasis
  
• Lack of ambulation per protocol
  
• Need for additional measures to achieve hemostasis (manual pressure, femostop use, etc.)
  
• Minor vascular complication (minor bleeding, analgesic use)
  
• post procedural myocardial infarction
  
• 30 day incidence of death, MI, TVR
  
• Patient discomfort
  
• Quality of life measurements at discharge and four weeks
  
• Nurse resource utilization at discharge
  

All patients scheduled to undergo percutaneous coronary interventions will be screened for inclusion into the study. Informed consent will be obtained and patients will be randomized to the placement of either Angioseal or a Starclose vascular closure device to achieve hemostasis after the PCI procedure. The randomization will take place after a femoral angiogram has confirmed the suitability of the femoral artery for placement of arterial closure device. All patients will be monitored for bleeding or hematoma formation for twelve hours after the procedure. Patients will be ambulated at two hours after placement of the arterial closure device. A complete blood count and a vascular ultrasound will be performed in all patients before discharge to assess blood loss and detect vascular complications such as hematoma, arteriovenous fistula or femoral artery pseudoaneurysm. A written quality of life survey will be completed before discharge and at four weeks. A nursing survey will be completed by the nursing staff to determine nurse-sensitive outcomes and nurse resource utilization.