Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-11-30

Brief Summary

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This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.

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Detailed Description

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285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study

Patients will receive cCTA, ICA, FFR, and cFFR per protocol.

Group Type OTHER

FFR

Intervention Type DEVICE

Fractional flow reserve measured during cardiac catheterization

Interventions

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FFR

Fractional flow reserve measured during cardiac catheterization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years
* Patients providing written informed consent
* Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography (ICA)
* Has undergone \>64 multidetector row CCTA within 60 days prior to ICA
* No cardiac interventional therapy between the CCTA and ICA

Exclusion Criteria

* Prior coronary artery bypass graft (CABG) surgery
* Prior percutaneous coronary intervention (PCI) for which suspected coronary artery lesion(s) are within a stented coronary vessel
* Contraindication to adenosine, including 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension, severe asthma, , severe COPD or bronchodilator-dependent COPD
* Suspicion of acute coronary syndrome (acute myocardial infarction and unstable angina)
* Recent prior myocardial infarction within 40 days of ICA
* Known complex congenital heart disease
* Prior pacemaker or internal defibrillator lead implantation
* Prosthetic heart valve
* Significant arrhythmia or tachycardia
* Impaired chronic renal function (serum creatinine \>1.5 mg/dl
* Patients with known anaphylactic allergy to iodinated contrast
* Pregnancy or unknown pregnancy status
* Body mass index \>35
* Patient requires an emergent procedure
* Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
* Any active, serious, life-threatening disease with a life expectancy of less than 2 months
* Inability to comply with study procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No