Last updated on December 2016

User Evaluation Study of SyncVision System With Software v4.X


Brief description of study

This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary physiology and X-ray system during routine clinical workflow. The purpose of this study is to collect Professional user feedback regarding clinical utility of the SyncVision 4.X system.

Detailed Study Description

The PREPARE II study will enroll a maximum of 200 patients in up to 5 sites. No follow-up will be performed. The PREPARE II study will only collect data during diagnostic angiogram or percutaneous coronary intervention (PCI) procedure, when performed as per standard hospital care.

Clinical Study Identifier: NCT02915991

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Aaron Frimerman, MD

The medical research and development fund for health services Hillel Yaffe
Hadera, Israel
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Ariel Roguin, MD, Prof.

Rambam Health Corporation
Haifa, Israel
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