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Clinical Trials/NCT05753085
NCT05753085
Withdrawn
Not Applicable

Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment

Barts & The London NHS Trust1 site in 1 country50 target enrollmentSeptember 1, 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Barts & The London NHS Trust
Enrollment
50
Locations
1
Primary Endpoint
To assess the superiority of IVUS-OCT over standalone IVUS in guiding PCI
Status
Withdrawn
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2026
End Date
December 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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,
  • 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,

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • To examine the safety of the IVUS- OCT catheter in patients undergoing angiography and IVUS-OCT assessment(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(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(Measured at procedure, at 1 week post procedure, at 1 month post procedure and 12 months post procedure)

Study Sites (1)

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