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VICTORIA Multi-Center Clinical Registry
A registry is an observational study structured to track outcomes of a treatment or procedure over time without controlling variables or randomizing groups. It is a non-experimental design aimed at evaluating broad groups of patients undergoing a similar treatment or procedure. Observed trends may lead to further study conducted in an experimental design to evaluate how the treatment or procedure compares to others or with respect to identified study variables.
The VICTORIA™ (Visual Interpretation of Completeness and Technical Operative Results using Intra-operative Arteriography) Multi-Center Clinical Registry has been started to track trends in coronary bypass surgery using the SPY® Intra-operative Imaging System.
The aims of the registry include:
- Documenting the utility of SPY imaging in the routine evaluation of CABG technical efficacy
- Establishing the imaging knowledge base to facilitate accurate and efficient image interpretation by surgeons using the SPY System at the time of surgery
- Providing information and experience to establish use of the SPY technology as a quality metric for CABG care in the US and worldwide
- Using the information acquired during SPY imaging to generate new insights into how to improve even further the short- and long-term outcomes of surgical revascularization
- Using the information gained from SPY technology as the backbone for dynamic, ongoing provider education and as the resource for generating high quality educational tools
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Initially, 10 sites will be selected for participation in the registry. These sites will collect simultaneously clinical and imaging information from enrolled patients undergoing isolated CABG. Patient data will include pre-operative, peri-operative, and 30 day post-operative data for all patients undergoing CABG with intra-operative angiography.
The coordinating center for the VICTORIA Registry is Eastern Carolina Cardiovascular Institute (ECCI) at the Brody School of Medicine at Eastern Carolina University (ECU) in Greenville, NC, under the overall direction of Dr. T. Bruce Ferguson. The VICTORIA Registry is accessible via a secure Internet Application. ARMUS Corporation provides a secure, on-line clinical registry application service to participating sites. VICTORIA Registry participants pass through a secure login to a web portal where advanced data entry and analysis tools are provided. The electronic Case Report Form (e-CRF) for the VICTORIA Registry is completed with the Outcomes 3™ electronic data capture service.
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