Clinical trial NCT05753085: Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment
Official title: Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Stenosis
Plaque, Atherosclerotic
Keywords: Coronary
Intravascular Imaging
Plaque
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Rosetrees Trust
name: NIHR Barts Biomedical Research Centre
name: Conavi Medical Inc
First posted: 2023-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the superiority of IVUS-OCT over standalone IVUS in guiding PCI
timeFrame: Measured at procedure
Secondary outcomes:
measure: To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and IVUS-OCT assessment
timeFrame: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
measure: To examine the safety of the IVUS- OCT imaging procedure
timeFrame: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
measure: To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and intravascular imaging
timeFrame: Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
state: England
Study officials:
affiliation: Barts & The London NHS Trust
name: Christos Bourantas
role: PRINCIPAL_INVESTIGATOR
References: