Novasight Hybrid Intravascular Ultrasou… | Clinical Trial

Key information

Conditions

Stable Angina Acute Coronary Syndrome Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

About this study

A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient is at least 18 years old.
Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
Patients with STEMI may be undergoing subsequent staged PCI to additional coronary stenoses after the index STEMI event has been successful treated with primary PCI.
Vascular access of at least 6F.
Patient provides informed, written consent for participation in the study.
A target lesion is present in a suitable artery for intravascular imaging.

Exclusion criteria

Angiographic evidence of severe calcification
Marked tortuosity that precludes imaging of a target coronary artery.
GFR (Glomerular filtration rate) <35 mL/min.
Patients in cardiogenic shock.
Women of child bearing potential, in whom pregnancy cannot be excluded.
Patients of age < 18 years old.
Patients with an allergy to contrast.
Patients unable to grant informed, written consent for participation in the study.

Treatment and study plan

Observation Group

Device

Collect coronary images with a hybrid IVUS OCT system.

Primary outcomes

Collection of the first human coronary images with the hybrid IVUS OCT technology

Time frame: Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the procedure.

The hybrid IVUS OCT system permits simultaneous and co-registered acquisition of IVUS and OCT coronary images. IVUS and/or OCT series can be recorded up to 10 cm of the vessel length or up to 20 s of imaging. The physician will review 10 frames and evaluate independently IVUS images, OCT images and the combined IVUS-OCT images for the ability to identify and characterize coronary lesion categories: lipid plaque, calcified plaque, fibrous plaque, thin fibrous cap, positive remodelling and plaque burden. Results, for each frame and imaging modality, of lesion assessment will be tabulated as: a) non-assessable, b) assessable and present, c) assessable and absent. The Clinical Report Form captures tabulated sections for each imaging modality and specific frame selected for lesion evaluation. Results will be presented qualitatively and quantitative as categorical calculations.

Image interpretation will be performed independently and blinded to clinical and angiographic information.

Sponsors and collaborators

Lead sponsor

Conavi

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2021
First posted: Apr 2, 2018
Registry last updated: Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed