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

Primary Purpose

Stable Angina, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Observation group
Sponsored by
Conavi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stable Angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Observation group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2018
Last Updated
August 28, 2021
Sponsor
Conavi
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1. Study Identification

Unique Protocol Identification Number
NCT03484975
Brief Title
Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)
Official Title
Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conavi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Collection of coronary images with a hybrid IVUS OCT system.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Acute Coronary Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Observation group
Intervention Description
Collect coronary images with a hybrid IVUS OCT system.
Primary Outcome Measure Information:
Title
Collection of the first human coronary images with the hybrid IVUS OCT technology
Description
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.
Time Frame
Clinical Report Forms (capturing image analysis) will be completed for each case no later then 72 hours after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tej Sheth, MD
Organizational Affiliation
Hamilton General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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