Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)

Collection of coronary images with a hybrid IVUS OCT system.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Stable Angina
• Intervention / Treatment: Device: Observation group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
3. 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.
4. Vascular access of at least 6F.
5. Patient provides informed, written consent for participation in the study.
6. A target lesion is present in a suitable artery for intravascular imaging.

Exclusion Criteria:

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

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
Other: Observation group; 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.	Device: Observation group; Collect coronary images with a hybrid IVUS OCT system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of the first human coronary images with the hybrid IVUS OCT technology	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.	Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the procedure.

Collaborators and Investigators

• Sponsor: Conavi
• Investigators: Principal Investigator: Tej Sheth, MD, Hamilton General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): August 6, 2019
• Study Completion (Actual): August 18, 2021

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Acute Coronary Syndrome; Angina, Stable
• Other Study ID Numbers: EXT-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No