The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02154295




Registration number
NCT02154295
Ethics application status
Date submitted
16/05/2014
Date registered
3/06/2014
Date last updated
3/06/2014

Titles & IDs
Public title
In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
Scientific title
Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study
Secondary ID [1] 0 0
0126
Universal Trial Number (UTN)
Trial acronym
SAVOIR2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Infraredx Test Catheter

Active Comparator: Eagle Eye Platinum - Eagle Eye Platinum Catheter as the comparator.

Active Comparator: Revolution - Revolution Catheter as the comparator

Active Comparator: TVC Insight 40MHz - TVC Insight as comparative catheter.

Active Comparator: Atlantis Pro - Atlantis Pro catheter as comparator


Treatment: Devices: Infraredx Test Catheter


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clarity of Image and ease of interpretation as measured by physician survey
Timepoint [1] 0 0
Day 0
Secondary outcome [1] 0 0
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters
Timepoint [1] 0 0
Day 0

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Screening
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
InfraReDx
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Australian Health and Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Adelaide Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02154295
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Samuel Sidharta, MBBS BMedSc
Address 0 0
Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Samuel Sidharta, MBBS BMedSc FRACP
Address 0 0
Country 0 0
Phone 0 0
0432 683 766
Fax 0 0
Email 0 0
samuel.sidharta@gmail.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02154295