Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment (MOUSA)

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 Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Plaque, Atherosclerotic; Coronary Stenosis
• Intervention / Treatment: Device: Conavi Medical Novasight Hybrid System intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: R&D Governance Administrator; Phone Number: +44 (0)20 7882 6826; Email: research.governance@qmul.ac.uk

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, EC1A 7BE
      • St Bartholomew's Hospital
      • Principal Investigator: Christos Bourantas
      • Contact: R&D Governance Administrator; Phone Number: +44 (0)20 7882 6826; Email: research.governance@qmul.ac.uk
      • Contact: Ruth Bowles; Phone Number: +44 (0) 20 3765 8704; Email: r.bowles@qmul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General Inclusion Criteria

1. Age ≥ 18 to ≤80 years
2. Patient has capacity and willing to consent
3. Must be able to understand English language adequately
4. Patient admitted with an NSTEMI listed for coronary angiography

Angiographic Inclusion Criteria 1) Culprit lesion amenable to PCI

Exclusion Criteria:

General exclusion criteria:

1. eGFR <45ml/min/1.73m²,
2. No known conditions with anticipated life expectancy <1 year,
3. History of heart transplantation,
4. History of Coronary Artery Bypass Grafts (CABG )
5. Intravenous contrast allergy or inability to receive treatment with aspirin, heparin, or thienopyridines,
6. Pregnant or lactating women
7. Decompensated heart failure, or known left ventricular ejection fraction ≤30%

Angiographic exclusion criteria:

1. TIMI 0 flow distally to the culprit lesion,
2. The culprit lesion is located in the left main stem or the ostium of the right coronary artery,
3. Patient that requires surgical revascularization,
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Conavi Medical Novasight Hybrid System intervention; 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)

Device: Conavi Medical Novasight Hybrid System intervention; 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; Other Names: IVUS & OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 at procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust
• Collaborators: Rosetrees Trust; NIHR Barts Biomedical Research Centre; Conavi Medical Inc
• Investigators: Principal Investigator: Christos Bourantas, Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Plaque; Coronary; Intravascular Imaging
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Coronary Stenosis; Plaque, Atherosclerotic
• Other Study ID Numbers: 268761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No