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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

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Infraredx Test Catheter

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No