Coronary Artery DiseaseMOUSANCT05753085
Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment
A study testing Conavi Medical Novasight Hybrid System intervention in people with Coronary Artery Disease and Coronary Stenosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This investigation is to see if the new Novasight Hybrid imaging catheter can safely and accurately provide two different types of images (IVUS and OCT) of the inside of heart vessels at the same time. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis, Plaque, Atherosclerotic
- What is being tested?
- Conavi Medical Novasight Hybrid System intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to 31 Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria
- Age ≥ 18 to ≤80 years
- Patient has capacity and willing to consent
- Must be able to understand English language adequately
- Patient admitted with an NSTEMI listed for coronary angiography
- Angiographic Inclusion Criteria 1) Culprit lesion amenable to PCI
Who cannot join
- General exclusion criteria:
- eGFR <45ml/min/1.73m²,
- No known conditions with anticipated life expectancy <1 year,
- History of heart transplantation,
- History of Coronary Artery Bypass Grafts (CABG )
- Intravenous contrast allergy or inability to receive treatment with aspirin, heparin, or thienopyridines,
Show all 15Show fewer
- Pregnant or lactating women
- Decompensated heart failure, or known left ventricular ejection fraction ≤30%
- Angiographic exclusion criteria:
- TIMI 0 flow distally to the culprit lesion,
- The culprit lesion is located in the left main stem or the ostium of the right coronary artery,
- Patient that requires surgical revascularization,
- Unfavourable anatomy for intravascular imaging (i.e., the culprit lesion is a chronic total occlusion or is located in a tortuous vessel where intravascular imaging is not feasible)
- Intraprocedural exclusion criteria:
- 1) If the patient demonstrates evidence of active ischemia or hemodynamic compromise of concern to the operator prior to first insertion of the imaging device (e.g., such as a complication caused by wiring the lesion or after pre-dilating prior to advancing the imaging device for the first time) the study procedure should not commence.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Bartholomew's Hospital
London, England, EC1A 7BE
About this study
This investigation is to see if the new Novasight Hybrid imaging catheter can safely and accurately provide two different types of images (IVUS and OCT) of the inside of heart vessels at the same time. The images will be compared against one type of image (IVUS) to see if providing two, improves identification of different types of plaque (fatty substances) and informs better treatment.
Atherosclerotic coronary artery disease is the name given to the development of plaques in the heart vessels. The plaques can cause narrowing in the vessels which may cause chest pain. Sometimes, plaques completely block the vessels causing a heart attack. This type of disease is the main cause of death worldwide.
Read more
Research shows that when the type of plaque causing problems is known, it can help understanding of which narrowing may get worse and cause a heart attack. This information can also help with deciding when and which treatment to provide.
Intravascular imaging is a way to assess the inside of the heart arteries. It involves passing a narrow catheter into the heart vessels. The catheter has a probe on its tip that emits light or an ultrasound signal. The signal is reflected by the vessel wall, back into the probe. A computer program interprets the signals and creates images of the inside of the arteries. There are two types of imaging catheters. One uses sound (Intravascular Ultrasound (IVUS)) and one uses light ((OCT) Optical Coherence Tomography) to produce different types of pictures of the vessels and plaques. The images produced by each type do not provide a full picture of the plaques on their own.
A new hybrid imaging catheter has been developed which has two probes at the tip, an IVUS probe and an OCT probe and can produce both types of images at the same time. It is likely that having both types of images is better for finding high-risk plaques and should lead to better, more specific treatment.
50 heart attack patients who need an angiogram will have images of their vessels taken during their treatment. Once the imaging is complete the patient will continue with their routine planned care.
The information from the images will be used to see how safe and accurate this new hybrid catheter is compared with the separate IVUS and OCT catheters, and also check to see if it is easier to identify plaques that might cause future problems. The study also aims to develop new ways to process and use the images from the hybrid catheter to better treat the plaques that cause the heart attack.
- Being tested
- Conavi Medical Novasight Hybrid System intervention
- Keywords
- Coronary, Intravascular Imaging, Plaque
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Plaque, Atherosclerotic, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conavi Medical Novasight Hybrid System interventionDevice
Also called IVUS & OCT
Patients for a coronary angiogram who meet the inclusion criteria and none of the exclusion criteria are enrolled. Participants are prepared for angiography and PCI procedure in the usual way. Radial or femoral artery cannulation is done under local anaesthetic and the angiogram performed as per standard practice. IVUS-OCT imaging of the culprit vessel using the Novasight Hybrid system is then performed. If image quality of the IVUS-OCT is suboptimal it will be repeated. If the IVUS-OCT catheter cannot cross the lesion, pre-dilatation is performed. The acquired IVUS-OCT images can be used to optimise PCI. Following PCI, angiography is repeated and if the findings are optimal, IVUS-OCT imaging is repeated. If the PCI results are suboptimal further stent optimisation is performed and IVUS-OCT imaging repeated; The procedure is then completed as clinically indicated. The participant will then receive conventional post PCI care
| Study group | Role | What they receive |
|---|---|---|
| Conavi Medical Novasight Hybrid System intervention | Experimental | Patients who present with non-ST elevation myocardial infarction (NSTEMI) and require an angiogram and or PCI will have intravascular imaging assessment of the culprit vessel using the Conavi Medical Hybrid System (Novasight Hybrid Catheter, Novasight Hybrid PIM, Novasight Hybrid Hummingbird Console) Receives: Device: Conavi Medical Novasight Hybrid System intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the superiority of IVUS-OCT over standalone IVUS in guiding PCI
The number of post PCI findings associated with worse outcomes (i.e., stent un-der expansion, major malappositions, major dissections, large thrombus burden and residual plaque at the edges of the stent) detected by the Conavi Medical Hybrid Imaging System and stand alone IVUS
Measured: Measured at procedure
Secondary outcomes (3)
To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and IVUS-OCT assessment
The number of device related complications (vessel perforation, dissection and acute vessel closure during or following IVUS-OCT imaging).
Measured: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
To examine the safety of the IVUS- OCT imaging procedure
The number of procedural complications defined as: vessel perforation, angiographic dissection, stent thrombosis, thrombus embolization and acute vessel closure.
Measured: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and intravascular imaging
The number of participant deaths or myocardial infarctions
Measured: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Concerns with capacity
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-centre, prospective, non-randomized, open-label feasibility study of the Conavi Medical Novasight Hybrid System (IVUS and OCT) for stent optimization and atheroma assessment in patients who present with non-ST elevation myocardial infarction (NSTEMI).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Rosetrees Trust, National Institute for Health Research, United Kingdom, Conavi Medical Inc
- Responsible party
- Sponsor
- Investigators
- Christos Bourantas, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753085
- Sponsor's protocol ID
- 268761
- Acronym
- MOUSA
- Status last verified
- Sep 2025
- First submitted
- 12 Jan 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment
- ClinicalTrials.gov ID
- NCT05753085
- Acronym / sponsor ID
- MOUSA / 268761
- Keywords
- Coronary, Intravascular Imaging, Plaque
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Concerns with capacity
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Rosetrees Trust, National Institute for Health Research, United Kingdom, Conavi Medical Inc
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2023 (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.
This investigation is to see if the new Novasight Hybrid imaging catheter can safely and accurately provide two different types of images (IVUS and OCT) of the inside of heart vessels at the same time. The images will be compared against one type of image (IVUS) to see if providing two, improves identification of different types of plaque (fatty substances) and informs better treatment.
Atherosclerotic coronary artery disease is the name given to the development of plaques in the heart vessels. The plaques can cause narrowing in the vessels which may cause chest pain. Sometimes, plaques completely block the vessels causing a heart attack. This type of disease is the main cause of death worldwide.
Research shows that when the type of plaque causing problems is known, it can help understanding of which narrowing may get worse and cause a heart attack. This information can also help with deciding when and which treatment to provide.
Intravascular imaging is a way to assess the inside of the heart arteries. It involves passing a narrow catheter into the heart vessels. The catheter has a probe on its tip that emits light or an ultrasound signal. The signal is reflected by the vessel wall, back into the probe. A computer program interprets the signals and creates images of the inside of the arteries. There are two types of imaging catheters. One uses sound (Intravascular Ultrasound (IVUS)) and one uses light ((OCT) Optical Coherence Tomography) to produce different types of pictures of the vessels and plaques. The images produced by each type do not provide a full picture of the plaques on their own.
A new hybrid imaging catheter has been developed which has two probes at the tip, an IVUS probe and an OCT probe and can produce both types of images at the same time. It is likely that having both types of images is better for finding high-risk plaques and should lead to better, more specific treatment.
50 heart attack patients who need an angiogram will have images of their vessels taken during their treatment. Once the imaging is complete the patient will continue with their routine planned care.
The information from the images will be used to see how safe and accurate this new hybrid catheter is compared with the separate IVUS and OCT catheters, and also check to see if it is easier to identify plaques that might cause future problems. The study also aims to develop new ways to process and use the images from the hybrid catheter to better treat the plaques that cause the heart attack.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-centre, prospective, non-randomized, open-label feasibility study of the Conavi Medical Novasight Hybrid System (IVUS and OCT) for stent optimization and atheroma assessment in patients who present with non-ST elevation myocardial infarction (NSTEMI).
| Arm | Type | Receives |
|---|---|---|
| Conavi Medical Novasight Hybrid System intervention | Experimental | Device: Conavi Medical Novasight Hybrid System interventionPatients who present with non-ST elevation myocardial infarction (NSTEMI) and require an angiogram and or PCI will have intravascular imaging assessment of the culprit vessel using the Conavi Medical Hybrid System (Novasight Hybrid Catheter, Novasight Hybrid PIM, Novasight Hybrid Hummingbird Console) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- General Inclusion Criteria
- Age ≥ 18 to ≤80 years
- Patient has capacity and willing to consent
- Must be able to understand English language adequately
- Patient admitted with an NSTEMI listed for coronary angiography
Key exclusion criteria (15 listed)
- eGFR <45ml/min/1.73m²,
- No known conditions with anticipated life expectancy <1 year,
- History of heart transplantation,
- History of Coronary Artery Bypass Grafts (CABG )
- Intravenous contrast allergy or inability to receive treatment with aspirin, heparin, or thienopyridines,
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 |
|---|---|---|
| Conavi Medical Novasight Hybrid System interventionAlso: IVUS & OCTPatients for a coronary angiogram who meet the inclusion criteria and none of the exclusion criteria are enrolled. Participants are prepared for angiography and PCI procedure in the usual way. Radial or femoral artery cannulation is done under local anaesthetic and the angiogram performed as per standard practice. IVUS-OCT imaging of the culprit vessel using the Novasight Hybrid system is then performed. If image quality of the IVUS-OCT is suboptimal it will be repeated. If the IVUS-OCT catheter cannot cross the lesion, pre-dilatation is performed. The acquired IVUS-OCT images can be used to optimise PCI. Following PCI, angiography is repeated and if the findings are optimal, IVUS-OCT imaging is repeated. If the PCI results are suboptimal further stent optimisation is performed and IVUS-OCT imaging repeated; The procedure is then completed as clinically indicated. The participant will then receive conventional post PCI care | Device | Conavi Medical Novasight Hybrid System intervention |
Primary outcome
To assess the superiority of IVUS-OCT over standalone IVUS in guiding PCI
Time frame: Measured at procedure
The number of post PCI findings associated with worse outcomes (i.e., stent un-der expansion, major malappositions, major dissections, large thrombus burden and residual plaque at the edges of the stent) detected by the Conavi Medical Hybrid Imaging System and stand alone IVUS
3 secondary outcomes
To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and IVUS-OCT assessment
Time frame: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
To examine the safety of the IVUS- OCT imaging procedure
Time frame: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and intravascular imaging
Time frame: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruitingObservational study
Assessment of Transnational Performance of the Universal Cardiac Surgical Risk Score Across International Sites
Heart Valve Diseases, Cardiac Surgical Procedures
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
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.
Christos Bourantas principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conavi Medical Novasight Hybrid System intervention in people with Coronary Artery Disease and Coronary Stenosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 15 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: withdrawn, as of the sponsor's last update on 17 Sep 2025. 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 Kingdom. 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 withdrawn before enrolling participants, so there are no results.
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?
To assess the superiority of IVUS-OCT over standalone IVUS in guiding PCI (time frame: Measured at 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 17 Sep 2025.