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

Launched by BARTS & THE LONDON NHS TRUST · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging tool called the Novasight Hybrid catheter, which can take two types of pictures of heart vessels at the same time. These images help doctors see different types of plaque, which can cause blockages in the arteries and lead to heart attacks. By using both types of imaging—one that uses sound (IVUS) and one that uses light (OCT)—the researchers hope to improve how well doctors can identify dangerous plaques and provide better treatment to patients with coronary artery disease.

To participate in this study, you need to be between 18 and 80 years old and have been admitted to the hospital with a specific type of heart issue called NSTEMI, which often requires an angiogram (a special test to look at the heart's blood vessels). If you join, you will have images taken of your heart vessels during your regular treatment, and then you will continue with your usual care afterward. The goal of this trial is to see if the hybrid catheter is safe and accurate, and if it helps doctors make better decisions about treatment for patients at risk of heart attacks.

Gender

ALL

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.