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

Coronary Artery Disease Clinical Trial

— SAVOIR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154295
• Other study ID #: 0126
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: December 2020
• Source: InfraReDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Infraredx Test Catheter

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (3)

Lead Sponsor	Collaborator
InfraReDx	Royal Adelaide Hospital, South Australian Health and Medical Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clarity of Image and ease of interpretation as measured by physician survey		Day 0
Secondary	Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters		Day 0