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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Infraredx Test Catheter

About this trial

This is an interventional screening trial for Coronary Artery Disease

Eligibility Criteria

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

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)

Sites / Locations

Royal Adelaide Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Eagle Eye Platinum

Revolution

TVC Insight 40MHz

Atlantis Pro

Arm Description

Eagle Eye Platinum Catheter as the comparator.

Revolution Catheter as the comparator

TVC Insight as comparative catheter.

Atlantis Pro catheter as comparator

Outcomes

Primary Outcome Measures

Clarity of Image and ease of interpretation as measured by physician survey

Secondary Outcome Measures

Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters

Full Information

NCT ID

NCT02154295

First Posted

May 16, 2014

Last Updated

December 10, 2020

Sponsor

Infraredx

Collaborators

South Australian Health and Medical Research Institute, Royal Adelaide Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02154295

Brief Title

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

Acronym

SAVOIR2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Infraredx

Collaborators

South Australian Health and Medical Research Institute, Royal Adelaide Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eagle Eye Platinum

Arm Type

Active Comparator

Arm Description

Eagle Eye Platinum Catheter as the comparator.

Arm Title

Revolution

Arm Type

Active Comparator

Arm Description

Revolution Catheter as the comparator

Arm Title

TVC Insight 40MHz

Arm Type

Active Comparator

Arm Description

TVC Insight as comparative catheter.

Arm Title

Atlantis Pro

Arm Type

Active Comparator

Arm Description

Atlantis Pro catheter as comparator

Intervention Type

Device

Intervention Name(s)

Infraredx Test Catheter

Primary Outcome Measure Information:

Title

Clarity of Image and ease of interpretation as measured by physician survey

Time Frame

Day 0

Secondary Outcome Measure Information:

Title

Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters

Time Frame

Day 0

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Sidharta, MBBS BMedSc

Organizational Affiliation

Royal Adelaide Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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