Clinical trials: Fractional Flow Reserve
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Left Anterior Descending Coronary Artery Stenosis
The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study
The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending…
- Trial name
- OPSENS (NCT03848650)
- Testing
- OpSens Medical OptoWire, FFR
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Coronary Artery Disease (CAD)
Comparison of Orbital Versus Rotational Atherectomy Effects On Coronary Microcirculation in PCI
The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older generation rotational atherectomy (RA) due…
- Trial name
- ORACLE (NCT03021577)
- Testing
- Orbital Atherectomy System (OAS), Rotablator Rotational Atherectomy System, Magnetic Resonance Imaging (MRI)
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Columbia University
Coronary Artery Disease
Side Branch FFR After Provisional Stenting
The purpose of this study is to predict any changes in the side branch after stenting the main branch blood vessel using three dimensional intravascular images. (Frequency domain optical coherence tomography FD OCT).
- Trial name
- ORBID-FFR (NCT03115580)
- Testing
- Rotational atherectomy, Cutting Balloon Angioplasty
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Coronary Artery Disease
Diagnostic Accuracy of On-line Quantitative Flow Ratio (QFR). FAVOR II Europe-Japan
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is assessed by calculation of the pressure in the vessel based on two angiographic projections.
- Trial name
- FAVOR II EJ (NCT02959814)
- Testing
- QFR (observational)
- Where
- 10 sites in Denmark, France and 5 more
- Volunteers
- 329 people
- Sponsor
- Aarhus University Hospital Skejby
Coronary Artery Disease
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
- Trial name
- NCT01132495
- Testing
- Stenting plus OMT, OMT, Standard of care
- Where
- 29 sites in United States, Belgium and 11 more
- Volunteers
- 1,170 people
- Sponsor
- Abbott Medical Devices
Heart Disease, Coronary, Chest Pain
The Computed Tomography-derived Fractional Flow Reserve STAT Trial
This study is designed to directly compare Standard Care and CT fractional flow reserve (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on heart computed tomography (CT) scans.
- Conditions
- Heart Disease, Coronary, Chest Pain, Acute Coronary Syndrome
- Trial name
- CTFFR-STAT (NCT03263806)
- Testing
- CTFFR-Guided Group Management, SOC Group Management
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Corewell Health East
Coronary Artery Disease, Acute Coronary Syndrome
PRESSUREwire Study
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice.
- Trial name
- NCT02935088
- Testing
- Fractional Flow Reserve
- Where
- 71 sites in United States, Austria and 13 more
- Volunteers
- 2,217 people
- Sponsor
- Abbott Medical Devices
Angina
Ranolazine Among Unrevascularized Chronic Stable Angina Patients
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study.
- Trial name
- IMWELL (NCT02265796)
- Testing
- Ranolazine, Sugar pill
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- North Florida Foundation for Research and Education
Angina, Stable Chest Pain
The Value of CT Fractional Flow Reserve
Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has high sensitivity and negative predictive value for the detection of coronary artery disease (CAD).
- Trial name
- VFFRCTA (NCT03026283)
- Testing
- HeartFLow CT-FFR
- Volunteers
- 586 people
- Sponsor
- Northwell Health
Atherosclerosis, Coronary
Validation of a Computed Tomography (CT) Based Fractional Flow Reserve (FFR) Software Using the 320 Detector Aquilion ONE CT Scanner.
Coronary Computed Tomography Angiography (CCTA) contrast opacification gradients and FFR-CT estimation can aid in the severity estimation of significant atherosclerotic lesions.
- Trial name
- NCT03149042
- Testing
- CCTA
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- State University of New York at Buffalo