Coronary Artery DiseaseNCT00973921
Comparison of StentOptimizer With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography
An observational study of Coronary Artery Disease, run by Paieon Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to determine the diagnostic efficiency and accuracy of using the StentOptimizer. The ability of StentOptimizer to influence post deployment treatment strategy will be assessed and compared to the IVUS system. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients that underwent IVUS guided stent implantation in the institution.
Who may be able to join
- Percutaneous coronary intervention indicated clinically.
- IVUS used as part of the standard procedure.
- Subject must be >=40 yrs.
- Subject must provide written informed consent.
Who cannot join
- Low image quality as determined by the investigator.
- Subject is pregnant or nursing.
- Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Comparison of StentOptimizer - an Angiography-based Post Deployment Stent Analysis Application With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography for Post Deployment Stent Analysis
The primary objective of this study is to determine the diagnostic efficiency and accuracy of using the StentOptimizer. The ability of StentOptimizer to influence post deployment treatment strategy will be assessed and compared to the IVUS system. In addition, the correlation of diameter measurements between the StentOptimizer, IVUS and 2D QCA will be assessed. The StentOptimizer software, IVUS and 2D QCA were all part of the clinical procedure outside the study. The analysis of post deployment treatment decisions and diameter measurements using those modalities retrospectively make this an observational study.
Read the detailed description
Stent under-expansion is defined as the minimum stent area by itself or compared with a predefined reference. It plays a role in the pathogenesis of adverse events following stent deployment. Stent under-expansion has been a consistent finding in IVUS reports of acute or subacute BMS or DES thrombosis.
Post intervention imaging can determine whether there is adequate stent expansion. Currently the only available tool for evaluation of properness of stent deployment is intravascular ultrasound (IVUS). IVUS procedure is invasive, labor intensified, associated with radiation and contrast media use, and is not free of complications. In many medical centers, IVUS is not used routinely because of lack of knowledge and expertise in reading it, and it's relatively high price.
The StentOptimizer is an angiography based software tool aimed to enhance visualization of deployed stents and to provide the physician with quantitative data regarding stent dimensions. The StentOptimizer is part of an image acquisition and processing software system (IC-Pro), designed as an add-on to conventional X-ray angiography systems.
An enhanced stent image is produced using the radiopaque markers of the delivery balloon from several frames (minimum 20). The result is a still image of the stent with enhanced edges and the region of interest around it
- Conditions
- Coronary Artery Disease
- Keywords
- Stent, under-expansion, StentOp, StentOptimizer, IVUS, IC-PRO, image enhancement
- 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 |
|---|---|---|
| Stent deployment evaluation | The study group consisted of patients that underwent IVUS guided stent implantation. Stent deployment evaluation was done with the experimental StentOptimizer as well as IVUS and QCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.
IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.
Measured: On the procedure day
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.
IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.
Measured: On procedure day
Secondary outcomes (2)
Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .
The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by SO and by IVUS.
Measured: On day of procedure
Correlation of Stent Diameter Measurements Between the QCA and IVUS .
The mean difference between stent diameter measurements at the narrowest point (Minimum Stent Diameter) by QCA and by IVUS
Measured: On day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paieon Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giora Weisz, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973921
- Sponsor's protocol ID
- Paieon-Columbia-SO
- Status last verified
- Mar 2014
- First submitted
- 6 Sep 2009
- Last updated
- 11 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of StentOptimizer - an Angiography-based Post Deployment Stent Analysis Application With IntraVenous Ultrasound and 2D Quantitative Coronary Angiography for Post Deployment Stent Analysis
- ClinicalTrials.gov ID
- NCT00973921
- Acronym / sponsor ID
- Paieon-Columbia-SO
- Conditions
- Coronary Artery Disease
- Keywords
- Stent, under-expansion, StentOp, StentOptimizer, IVUS, IC-PRO, image enhancement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Paieon Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Posted 11 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the diagnostic efficiency and accuracy of using the StentOptimizer. The ability of StentOptimizer to influence post deployment treatment strategy will be assessed and compared to the IVUS system. In addition, the correlation of diameter measurements between the StentOptimizer, IVUS and 2D QCA will be assessed. The StentOptimizer software, IVUS and 2D QCA were all part of the clinical procedure outside the study. The analysis of post deployment treatment decisions and diameter measurements using those modalities retrospectively make this an observational study.
Detailed description
Stent under-expansion is defined as the minimum stent area by itself or compared with a predefined reference. It plays a role in the pathogenesis of adverse events following stent deployment. Stent under-expansion has been a consistent finding in IVUS reports of acute or subacute BMS or DES thrombosis.
Post intervention imaging can determine whether there is adequate stent expansion. Currently the only available tool for evaluation of properness of stent deployment is intravascular ultrasound (IVUS). IVUS procedure is invasive, labor intensified, associated with radiation and contrast media use, and is not free of complications. In many medical centers, IVUS is not used routinely because of lack of knowledge and expertise in reading it, and it's relatively high price.
The StentOptimizer is an angiography based software tool aimed to enhance visualization of deployed stents and to provide the physician with quantitative data regarding stent dimensions. The StentOptimizer is part of an image acquisition and processing software system (IC-Pro), designed as an add-on to conventional X-ray angiography systems.
An enhanced stent image is produced using the radiopaque markers of the delivery balloon from several frames (minimum 20). The result is a still image of the stent with enhanced edges and the region of interest around it
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stent deployment evaluation | – | –The study group consisted of patients that underwent IVUS guided stent implantation. Stent deployment evaluation was done with the experimental StentOptimizer as well as IVUS and QCA. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients that underwent IVUS guided stent implantation in the institution.
Key inclusion criteria (4 listed)
- Percutaneous coronary intervention indicated clinically.
- IVUS used as part of the standard procedure.
- Subject must be >=40 yrs.
- Subject must provide written informed consent.
Key exclusion criteria (3 listed)
- Low image quality as determined by the investigator.
- Subject is pregnant or nursing.
- Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
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
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard.
Time frame: On the procedure day
IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, The SO software was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on QCA Analysis, With IVUS as Gold Standard.
Time frame: On procedure day
IVUS was used as a gold standard to decide if a stent required post dilatation or not. Independently and blindly, QCA analysis was used to determine the same decisions. The accuracy of SO was determined as the percentage of correct decisions compared to the gold standard.
2 secondary outcomes
Correlation of Stent Diameter Measurements Between the StentOptimizer and IVUS .
Time frame: On day of procedure
Correlation of Stent Diameter Measurements Between the QCA and IVUS .
Time frame: On day of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Giora Weisz, MD principal investigator
Columbia University
1 site 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 Paieon Inc. at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Accuracy (Percent of Correct Decisions) of Post-dilatation Decisions Based on the Stent Optimizer (SO) Software, With IVUS as Gold Standard. (time frame: On the procedure day). The study lists 2 primary outcomes in all. 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 11 Apr 2014.