In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems (SAVOIR2)

Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study

The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Infraredx Test Catheter

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥18 years of age
• Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
• Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
• Target artery must be >2 mm to accommodate the IVUS catheter.
• IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)

Exclusion Criteria:

• Cardiogenic shock
• Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
• Known coronary artery spasm
• Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
• Bleeding diathesis
• Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Eagle Eye Platinum; Eagle Eye Platinum Catheter as the comparator.	Device: Infraredx Test Catheter
Active Comparator: Revolution; Revolution Catheter as the comparator	Device: Infraredx Test Catheter
Active Comparator: TVC Insight 40MHz; TVC Insight as comparative catheter.	Device: Infraredx Test Catheter
Active Comparator: Atlantis Pro; Atlantis Pro catheter as comparator	Device: Infraredx Test Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clarity of Image and ease of interpretation as measured by physician survey	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters	Day 0

Collaborators and Investigators

• Sponsor: Infraredx
• Collaborators: Royal Adelaide Hospital; South Australian Health and Medical Research Institute
• Investigators: Principal Investigator: Samuel Sidharta, MBBS BMedSc, Royal Adelaide Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 0126