AtherosclerosisSAVOIRNCT00901446
Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter
An observational study of Atherosclerosis and Coronary Artery Disease, run by Infraredx at 1 site in Netherlands.
Trial summary
This study is designed to evaluate the technical performance and clinical handling of a coronary catheter that includes two imaging techniques. The catheter being evaluated performs near infrared spectroscopy and ultrasound imaging of the coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- Intravascular ultrasound and spectroscopy
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to May 2010
- 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: Subjects will be recruited from the patients presenting to the cardiac catheterization laboratory for elective cardiac catheterization.
Who may be able to join
- >=18yrs of age.
- diagnosed with stable angina pectoris or documented silent ischemia
- scheduled for elective, non-emergent cardiac catheterization
- able to read, understand, and provide written informed consent
- >=1 obstructive stenosis (>50%DS by visual estimate)in a major native coronary artery
- clinically indicated treatment plan includes placement of a guidewire into the target artery.
- target artery has a >=30mm segment with a reference vessel diameter >=2.5mm
- target artery has a >50%DS luminal narrowing
Who cannot join
- Subject unwilling or unable to provide written informed consent.
- Subject unwilling to comply with protocol
- Subject is pregnant
- Subject is of childbearing potential without negative pregnancy test.
- Subject received prolonged CPR within 2 weeks of enrollment procedure
- Subject is intubated.
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- Subject is diagnosed with an acute coronary syndrome.
- Subject has severe persistent hypertension.
- Subject has renal dysfunction or insufficiency.
- Subject has an abnormal platelet count.
- Subject has low hemoglobin levels.
- Subject has active liver disease or dysfunction.
- subject diagnosed with acute pulmonary edema or congestive heart failure.
- Subject diagnosed or suspected to have acute myo-, peri-, or endo- carditis, cardiac tamponade, or dissected aortic aneurysm.
- Subject has significant valvular heart disease, cardiomyopathy, or congenital heart disease.
- Subject has history of intracranial bleeding or aneurysm.
- Subject has a history of stroke that precludes the use of routine antithrombotic agents during PCI?
- Subject has known hypercoagulable state, coagulopathy, or abnormal bleeding.
- subject has family history of coagulopathy or bleeding diathesis.
- subject has undergone PCI in the last 30days.
- subject enrolled or participating in pharmaceutical study in last 30 days.
- subject enrolled or participating in medical device treatment study in last 30 days.
- subject has obstructive LMCA disease.
- subject has multivessel CAD that requires additional treatment in a separate procedure with 30days of enrollment.
- subject has unprotected left main disease.
- three vessel intervention is required during enrollment procedure.
- target artery is the left circumflex artery.
- target artery is accessed through a vein or arterial graft.
- target artery is tortuous
- target artery contains segments of severe calcification
- target artery has >2 serial obstructions exceeding 50%DS.
- target artery has an aneurysm or suspected aneurysm.
- target artery has <=1 TIMI flow.
- target lesion is >99% DS.
- target lesion is severely calcified
- target lesion has angiographic characteristics of thrombus.
- target lesion has angiographic characteristics of ulceration.
- target lesion has inclusion of a side branch greater than 1mm.
- target lesion is located in a vessel segment with >4.0mm reference vessel diameter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study
This study is designed to evaluate the technical performance and clinical handling of a coronary catheter that includes two imaging techniques. The catheter being evaluated performs near infrared spectroscopy and ultrasound imaging of the coronary arteries. Near infrared spectroscopy is used to identify lipid or cholesterol deposits in the vessel wall and the ultrasound component provides structural information about the vessel. Combining multiple imaging techniques into a single catheter can reduce the total number of catheters required during treatment and the overall duration of cardiac catheterization. Both of these results may lead to safer procedures.
- Being tested
- Intravascular ultrasound and spectroscopy
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular ultrasound and spectroscopyDevice
Also called InfraReDx
Intracoronary imaging with a catheter based ultrasound transducer and near infrared spectroscopy tip that is pulled back at an automated rate of 0.5 millimeters per second.
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Subjects who receive intracoronary imaging with the investigative device. Receives: Device: Intravascular ultrasound and spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.
Measured: day 0
Secondary outcomes (4)
The imaging tip can be positioned in the mid segment of the target artery.
Measured: day 0
The lumen boundary of the target stenosis can be distinguished within the IVUS data set.
Measured: day 0
The external elastic membrane (EEM) of the target stenosis can be distinguished within the IVUS data set.
Measured: day 0
The lumen and EEM can be distinguished in the same cross section of the IVUS data set.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Infraredx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick Serruys, MD, Principal investigator, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901446
- Sponsor's protocol ID
- 0112
- Acronym
- SAVOIR
- Status last verified
- Sep 2010
- First submitted
- 11 May 2009
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study
- ClinicalTrials.gov ID
- NCT00901446
- Acronym / sponsor ID
- SAVOIR / 0112
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- InfraredxIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 13 May 2009 (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 study is designed to evaluate the technical performance and clinical handling of a coronary catheter that includes two imaging techniques. The catheter being evaluated performs near infrared spectroscopy and ultrasound imaging of the coronary arteries. Near infrared spectroscopy is used to identify lipid or cholesterol deposits in the vessel wall and the ultrasound component provides structural information about the vessel. Combining multiple imaging techniques into a single catheter can reduce the total number of catheters required during treatment and the overall duration of cardiac catheterization. Both of these results may lead to safer procedures.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | – | Device: Intravascular ultrasound and spectroscopySubjects who receive intracoronary imaging with the investigative device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the patients presenting to the cardiac catheterization laboratory for elective cardiac catheterization.
Key inclusion criteria (8 listed)
- >=18yrs of age.
- diagnosed with stable angina pectoris or documented silent ischemia
- scheduled for elective, non-emergent cardiac catheterization
- able to read, understand, and provide written informed consent
- >=1 obstructive stenosis (>50%DS by visual estimate)in a major native coronary artery
Key exclusion criteria (39 listed)
- Subject unwilling or unable to provide written informed consent.
- Subject unwilling to comply with protocol
- Subject is pregnant
- Subject is of childbearing potential without negative pregnancy test.
- Subject received prolonged CPR within 2 weeks of enrollment procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular ultrasound and spectroscopyAlso: InfraReDxIntracoronary imaging with a catheter based ultrasound transducer and near infrared spectroscopy tip that is pulled back at an automated rate of 0.5 millimeters per second. | Device | Imaging |
Primary outcome
Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.
Time frame: day 0
4 secondary outcomes
The imaging tip can be positioned in the mid segment of the target artery.
Time frame: day 0
The lumen boundary of the target stenosis can be distinguished within the IVUS data set.
Time frame: day 0
The external elastic membrane (EEM) of the target stenosis can be distinguished within the IVUS data set.
Time frame: day 0
The lumen and EEM can be distinguished in the same cross section of the IVUS data set.
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
- Sponsor WebsiteLink provided by the sponsor.
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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.
Patrick Serruys, MD principal investigator
Erasmus Medical Centre
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 Atherosclerosis and Coronary Artery Disease, run by Infraredx at 1 site in Netherlands.
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 8 inclusion and 39 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 14 Sep 2010. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run. (time frame: day 0). 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 Sep 2010.