User Evaluation Study of SyncVision System With Software v4.X (Prepare II)

Volcano

Status: Terminated

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02915991

2016-CV-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

All patients

Description:

This is a single-arm study, so all patients enrolled will be in this arm and will undergo diagnostic catheterization procedure as per standard hospital care.