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
1 other identifier
interventional
16
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started May 2014
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
June 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedDecember 14, 2020
December 1, 2020
3 months
May 16, 2014
December 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clarity of Image and ease of interpretation as measured by physician survey
Day 0
Secondary Outcomes (1)
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters
Day 0
Study Arms (4)
Eagle Eye Platinum
ACTIVE COMPARATOREagle Eye Platinum Catheter as the comparator.
Revolution
ACTIVE COMPARATORRevolution Catheter as the comparator
TVC Insight 40MHz
ACTIVE COMPARATORTVC Insight as comparative catheter.
Atlantis Pro
ACTIVE COMPARATORAtlantis Pro catheter as comparator
Interventions
Eligibility Criteria
You may qualify if:
- ≥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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Infraredxlead
- South Australian Health and Medical Research Institutecollaborator
- Royal Adelaide Hospitalcollaborator
Study Sites (1)
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Sidharta, MBBS BMedSc
Royal Adelaide Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2014
First Posted
June 3, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 14, 2020
Record last verified: 2020-12