User Evaluation Study of SyncVision System With Software v4.X

Coronary Artery Disease Clinical Trial

— Prepare II  

Official title:

Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02915991
• Other study ID #: 2016-CV-001
• Status: Terminated
• Start date: November 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients eligible and indicated for cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice

• Males over the age of 18 years and post-menopausal females

• Patient is able to give written informed consent prior to using his/her study data for evaluation and documentation

Exclusion Criteria:

• Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	The medical research and development fund for health services Hillel Yaffe	Hadera
Israel	Rambam Health Corporation	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Professional user feedback regarding clinical utility of the SyncVision 4.X system	After the procedure the physician will be asked to rate and comment on the clinical utility and features of the SyncVision 4.X system in the post-study user evaluation questionnaire. This will include questions on the potential of the system to facilitate clinical decision-making, utility of co-registration workflow and functionality, quality of the co-registration and user interface functions.	Day 1 (Post-Procedure)
Secondary	Difference between assessments	Differences between the clinical assessment based on the existing time-based pullback graph and clinical assessment based on the automated co-registration of pullback graph with the angio image are performed by using a rating system 1 - 5 (1=Unacceptable, …., 5=Excellent).; The co-registration and functionality points assessed are: Workflow associated with achieving Physiology values co-registration; Physiology values co-registration results display clear and functionality convenient for use; Angiogram & Roadmap selection; Auto roadmap generation; Pathway indication and correction; Co-Registration sequence: Roadmap-navigation and calibrated graph navigation; Length measurements	Day 1 (Post-Procedure)
Secondary	Distinguish tandem, diffuse and mixed disease	Ability to distinguish tandem, diffuse and mixed disease based on the physiological pullback profile display and the co-registered physiological pullback profile display are performed by the use of a rating system 1 - 5 (1=Unacceptable, …., 5=Excellent). The points assessed and compared are: Distinguish tandem lesions; Distinguish diffuse diseased lesions; Distinguish mixed diseased lesions	Day 1 (Post-Procedure)
Secondary	Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values	Comparison of the pre-intervention expected distal-most iFR with the post-intervention actual distal-most iFR values is based on the comparison of real time pre- and post-intervention displayed iFR values on the physiological pullback profile display and the co-registered physiological pullback profile display.The points assessed and compared are: Pre-intervention distal most iFR; Post-intervention iFR	Day 1 (Post-Procedure)