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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Infraredx Test Catheter

• Registration Number: NCT02154295
• Lead Sponsor: Infraredx

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eagle Eye Platinum	Infraredx Test Catheter	Eagle Eye Platinum Catheter as the comparator.
Revolution	Infraredx Test Catheter	Revolution Catheter as the comparator
TVC Insight 40MHz	Infraredx Test Catheter	TVC Insight as comparative catheter.
Atlantis Pro	Infraredx Test Catheter	Atlantis Pro catheter as comparator

Primary Outcome Measures

Name	Time	Method
Clarity of Image and ease of interpretation as measured by physician survey	Day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia