Stable AnginaNCT03484975
Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)
A study testing Observation group in people with Stable Angina and Acute Coronary Syndrome, run by Conavi at 1 site in Canada.
Trial summary
Collection of coronary images with a hybrid IVUS OCT system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Acute Coronary Syndrome
- What is being tested?
- Observation group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2018to 18 Aug 2021
- 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
- Patient is at least 18 years old.
- Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
- Patients with STEMI may be undergoing subsequent staged PCI to additional coronary stenoses after the index STEMI event has been successful treated with primary PCI.
- Vascular access of at least 6F.
- Patient provides informed, written consent for participation in the study.
- A target lesion is present in a suitable artery for intravascular imaging.
Who cannot join
- Angiographic evidence of severe calcification
- Marked tortuosity that precludes imaging of a target coronary artery.
- GFR (Glomerular filtration rate) <35 mL/min.
- Patients in cardiogenic shock.
- Women of child bearing potential, in whom pregnancy cannot be excluded.
- Patients of age < 18 years old.
- Patients with an allergy to contrast.
- Patients unable to grant informed, written consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Collection of coronary images with a hybrid IVUS OCT system.
Read the detailed description
A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.
- Conditions
- Stable Angina, Acute Coronary Syndrome
- Being tested
- Observation group
- Medical subject headings
- Angina, Stable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation groupDevice
Collect coronary images with a hybrid IVUS OCT system.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Other | Patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome. Receives: Device: Observation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of the first human coronary images with the hybrid IVUS OCT technology
The hybrid IVUS OCT system permits simultaneous and co-registered acquisition of IVUS and OCT coronary images. IVUS and/or OCT series can be recorded up to 10 cm of the vessel length or up to 20 s of imaging. The physician will review 10 frames and evaluate independently IVUS images, OCT images and the combined IVUS-OCT images for the ability to identify and characterize coronary lesion categories: lipid plaque, calcified plaque, fibrous plaque, thin fibrous cap, positive remodelling and plaque burden. Results, for each frame and imaging modality, of lesion assessment will be tabulated as: a) non-assessable, b) assessable and present, c) assessable and absent. The Clinical Report Form captures tabulated sections for each imaging modality and specific frame selected for lesion evaluation. Results will be presented qualitatively and quantitative as categorical calculations.
Image interpretation will be performed independently and blinded to clinical and angiographic information.
Measured: Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Aug 2018
- Primary completion6 Aug 2019
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conavi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tej Sheth, MD, Principal investigator, Hamilton General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484975
- Sponsor's protocol ID
- EXT-020
- Status last verified
- Aug 2021
- First submitted
- 12 Mar 2018
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)
- ClinicalTrials.gov ID
- NCT03484975
- Acronym / sponsor ID
- EXT-020
- Conditions
- Stable Angina, Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ConaviIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 2 Apr 2018 (actual)
- 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.
Collection of coronary images with a hybrid IVUS OCT system.
Detailed description
A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | Other | Device: Observation groupPatients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is at least 18 years old.
- Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
- Patients with STEMI may be undergoing subsequent staged PCI to additional coronary stenoses after the index STEMI event has been successful treated with primary PCI.
- Vascular access of at least 6F.
- Patient provides informed, written consent for participation in the study.
Key exclusion criteria (8 listed)
- Angiographic evidence of severe calcification
- Marked tortuosity that precludes imaging of a target coronary artery.
- GFR (Glomerular filtration rate) <35 mL/min.
- Patients in cardiogenic shock.
- Women of child bearing potential, in whom pregnancy cannot be excluded.
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 |
|---|---|---|
| Observation groupCollect coronary images with a hybrid IVUS OCT system. | Device | Observation group |
Primary outcome
Collection of the first human coronary images with the hybrid IVUS OCT technology
Time frame: Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the procedure.
The hybrid IVUS OCT system permits simultaneous and co-registered acquisition of IVUS and OCT coronary images. IVUS and/or OCT series can be recorded up to 10 cm of the vessel length or up to 20 s of imaging. The physician will review 10 frames and evaluate independently IVUS images, OCT images and the combined IVUS-OCT images for the ability to identify and characterize coronary lesion categories: lipid plaque, calcified plaque, fibrous plaque, thin fibrous cap, positive remodelling and plaque burden. Results, for each frame and imaging modality, of lesion assessment will be tabulated as: a) non-assessable, b) assessable and present, c) assessable and absent. The Clinical Report Form captures tabulated sections for each imaging modality and specific frame selected for lesion evaluation. Results will be presented qualitatively and quantitative as categorical calculations. Image interpretation will be performed independently and blinded to clinical and angiographic information.
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 31 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Tej Sheth, MD principal investigator
Hamilton General 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 Observation group in people with Stable Angina and Acute Coronary Syndrome, run by Conavi at 1 site in Canada.
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 6 inclusion and 8 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 31 Aug 2021. 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 Canada. 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?
Collection of the first human coronary images with the hybrid IVUS OCT technology (time frame: Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the 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 31 Aug 2021.