In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems (SAVOIR2)

Infraredx

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Infraredx Test Catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02154295

0126

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Eagle Eye Platinum

Active Comparator group

Description:

Eagle Eye Platinum Catheter as the comparator.

Treatment:

Device: Infraredx Test Catheter

Revolution

Active Comparator group

Description:

Revolution Catheter as the comparator

Treatment:

Device: Infraredx Test Catheter

TVC Insight 40MHz

Active Comparator group

Description:

TVC Insight as comparative catheter.

Treatment:

Device: Infraredx Test Catheter

Atlantis Pro

Active Comparator group

Description:

Atlantis Pro catheter as comparator

Treatment:

Device: Infraredx Test Catheter