None listed
Conditions
Brief summary
The purpose of this study is to assess the utility of a simple device that reduces coronary contrast reflux in STEMI patients undergoing percutaneous coronary intervention. The safety and efficacy of this device has recently been demonstrated in Alfred Hospital Study a performed at The Alfred Hospital (Project 347/12) in patients undergoing routine coronary angiography and non-acute PCI. This study showed that the device reduced overall contrast requirement by approximately 40%.
Interventions
The purpose of this study is to assess the utility of a simple device that reduces coronary contrast reflux in STEMI patients undergoing percutaneous coronary intervention. The investigational device is a metal fixture designed to be affixed to an IV pole or be placed on a surface outside the sterile field. The fixture holds a standard injection syringe (provided separately). The ‘fixture’ comprises a holder for a standard sterile syringe and an adjustable metal weight that is applied to the plunger of the syringe. The purpose of the weight is to provide a constant resistive force. Sterile tubing attached to the syringe is coupled to a standard injection circuit at the manifold or via an additional 3-way stop-cock. In this way, the syringe serves as a reservoir during injections of contrast media routing a portion of contrast media away from the coronary catheter and attenuating the pressure that is supplied to the catheter’s hub. The affect of the system can be modified by adding or subtracting weights to the fixture, thereby changing the force applied to the reservoir syringe. The system can be completely bypassed by simply turning a stopcock.
Sponsors
Study design
Eligibility
Inclusion criteria
Patient undergoing primary percutaneous coronary intervention for STEMI
Exclusion criteria
Refusal of or inability to provide consent