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Completed

NCT Number: NCT02154295

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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Infraredx Test Catheter

Device

Primary outcomes

  1. Clarity of Image and ease of interpretation as measured by physician survey

    Time frame: Day 0

Secondary outcomes

  1. Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Infraredx

Industry

Collaborators

  • Royal Adelaide Hospital
  • South Australian Health and Medical Research Institute

Registry information

Official study title

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

Acronym: SAVOIR2

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 3, 2014
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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