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Evaluating the effect of Limiting Radiographic Contrast Use in Patients Undergoing Emergent Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarct by Reflux Reduction.

Evaluating the effect of Limiting Radiographic Contrast Use in Patients Undergoing Emergent Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarct by Reflux Reduction.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000135718
Enrollment
20
Registered
2013-02-04
Start date
2013-03-01
Completion date
2014-12-18
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

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

Prof David Kaye
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Patient undergoing primary percutaneous coronary intervention for STEMI

Exclusion criteria

Refusal of or inability to provide consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026