Coronary Artery DiseaseSAVOIR2NCT02154295
In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
A study testing Infraredx Test Catheter in people with Coronary Artery Disease, run by Infraredx at 1 site in Australia.
Trial summary
The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Infraredx Test Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- May 2014to Aug 2014
- Phase
- Interventional
- 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
Who may be able to join
- ≥18 years of age
- Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
- Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
- Target artery must be >2 mm to accommodate the IVUS catheter.
- IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
Who cannot join
- Cardiogenic shock
- Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
- Known coronary artery spasm
- Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
- Bleeding diathesis
- Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
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
The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.
- Conditions
- Coronary Artery Disease
- Being tested
- Infraredx Test Catheter
- 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.
Infraredx Test CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Eagle Eye Platinum | Active comparator | Eagle Eye Platinum Catheter as the comparator. Receives: Device: Infraredx Test Catheter |
| Revolution | Active comparator | Revolution Catheter as the comparator Receives: Device: Infraredx Test Catheter |
| TVC Insight 40MHz | Active comparator | TVC Insight as comparative catheter. Receives: Device: Infraredx Test Catheter |
| Atlantis Pro | Active comparator | Atlantis Pro catheter as comparator Receives: Device: Infraredx Test Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clarity of Image and ease of interpretation as measured by physician survey
Measured: Day 0
Secondary outcomes (1)
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters
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 posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infraredx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- South Australian Health and Medical Research Institute, Royal Adelaide Hospital
- Responsible party
- Sponsor
- Investigators
- Samuel Sidharta, MBBS BMedSc, Principal investigator, Royal Adelaide Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154295
- Sponsor's protocol ID
- 0126
- Acronym
- SAVOIR2
- Status last verified
- Dec 2020
- First submitted
- 16 May 2014
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. 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
- NCT02154295
- Acronym / sponsor ID
- SAVOIR2 / 0126
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- InfraredxIndustry (pharma, biotech, devices)
- Collaborators
- South Australian Health and Medical Research Institute, Royal Adelaide Hospital
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Jun 2014 (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.
The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eagle Eye Platinum | Active comparator | Device: Infraredx Test CatheterEagle Eye Platinum Catheter as the comparator. |
| Revolution | Active comparator | Device: Infraredx Test CatheterRevolution Catheter as the comparator |
| TVC Insight 40MHz | Active comparator | Device: Infraredx Test CatheterTVC Insight as comparative catheter. |
| Atlantis Pro | Active comparator | Device: Infraredx Test CatheterAtlantis Pro catheter as comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
- Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
- Target artery must be >2 mm to accommodate the IVUS catheter.
- IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
Key exclusion criteria (6 listed)
- Cardiogenic shock
- Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
- Known coronary artery spasm
- Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
- Bleeding diathesis
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 |
|---|---|---|
| Infraredx Test Catheter | Device | Atlantis Pro, Eagle Eye Platinum, Revolution, TVC Insight 40MHz |
Primary outcome
Clarity of Image and ease of interpretation as measured by physician survey
Time frame: Day 0
1 secondary outcome
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters
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 Dec 2020.
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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.
Samuel Sidharta, MBBS BMedSc principal investigator
Royal Adelaide Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraredx Test Catheter in people with Coronary Artery Disease, run by Infraredx at 1 site in Australia.
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 5 inclusion and 6 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 Dec 2020. 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 Australia. 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?
Clarity of Image and ease of interpretation as measured by physician survey (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 Dec 2020.