Trials / Terminated
TerminatedNCT02915991
User Evaluation Study of SyncVision System With Software v4.X
Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Volcano Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2016-09-27
- Last updated
- 2018-05-14
Locations
2 sites across 1 country: Israel
Source: ClinicalTrials.gov record NCT02915991. Inclusion in this directory is not an endorsement.