Coronary Artery DiseasePrepare IINCT02915991
User Evaluation Study of SyncVision System With Software v4.X
An observational study of Coronary Artery Disease, run by Volcano Corporation at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 35 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patiets that undergo a cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice.
Who may be able to join
- 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
Who cannot join
- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The medical research and development fund for health services Hillel Yaffe
Hadera, 38100
Rambam Health Corporation
Haifa, 3109601
About this study
Official title: Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X
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.
Read the 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
- Coronary Artery Disease
- Keywords
- Coronary catheterization, Instantaneous wave free ratio (iFR), Fractional Flow Reserve (FFR), automated co-registration
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (Post-Procedure)
Secondary outcomes (3)
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
Measured: Day 1 (Post-Procedure)
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
Measured: Day 1 (Post-Procedure)
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
Measured: Day 1 (Post-Procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: slow recruitment and change in regulatory landscape
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Frimerman, Professor, Principal investigator, The medical research and development fund for health services Hillel YafeAriel Roguin, Professor, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915991
- Sponsor's protocol ID
- 2016-CV-001
- Acronym
- Prepare II
- Status last verified
- May 2018
- First submitted
- 16 Jun 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X
- ClinicalTrials.gov ID
- NCT02915991
- Acronym / sponsor ID
- Prepare II / 2016-CV-001
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary catheterization, Instantaneous wave free ratio (iFR), Fractional Flow Reserve (FFR), automated co-registration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow recruitment and change in regulatory landscape
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patiets that undergo a cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Professional user feedback regarding clinical utility of the SyncVision 4.X system
Time frame: Day 1 (Post-Procedure)
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.
3 secondary outcomes
Difference between assessments
Time frame: Day 1 (Post-Procedure)
Distinguish tandem, diffuse and mixed disease
Time frame: Day 1 (Post-Procedure)
Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values
Time frame: Day 1 (Post-Procedure)
Results and safety
The study was stopped early (reason given: slow recruitment and change in regulatory landscape). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Frimerman, Professor principal investigator
The medical research and development fund for health services Hillel Yafe
Ariel Roguin, Professor principal investigator
Rambam Healthcare Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Volcano Corporation at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruitment and change in regulatory landscape). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Professional user feedback regarding clinical utility of the SyncVision 4.X system (time frame: Day 1 (Post-Procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.