Clinical trials: Myocardial Fractional Flow Reserve
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
The aim of this study is to establish the diagnostic performance of the AngioAI+ System (AngioInsight, Inc, USA) for estimating: 1. Fractional flow reserve (FFR) and 2.
- Trial name
- SMARTFLOW (NCT07676097)
- Testing
- Patients with intermediate coronary artery stenosis with clinically indicated FFR assessment., Microvascular assessment
- Where
- 9 sites in United States
- Volunteers
- 620 people
- Sponsor
- AngioInsight
Coronary Disease
The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses
The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac…
- Trial name
- DEFINE REAL (NCT02281110)
- Testing
- iFR/FFR
- Where
- Belgium
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Coronary Artery Disease
FAME II-10-year Follow-Up
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design.
- Trial name
- FAME2-10yFU (NCT06159231)
- Where
- 16 sites in United States, Belgium and 9 more
- Volunteers
- 888 people
- Sponsor
- CoreAalst BV
Coronary Artery Disease
User Evaluation Study of SyncVision System With Software v4.X
This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary…
- Trial name
- Prepare II (NCT02915991)
- Where
- 2 sites in Israel
- Volunteers
- 35 people
- Sponsor
- Volcano Corporation
Coronary Artery Disease
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization.
- Trial name
- FAST III (NCT04931771)
- Testing
- vFFR guided revascularization, FFR guided revascularization
- Where
- 40 sites in France, Germany and 5 more
- Volunteers
- 2,235 people
- Sponsor
- ECRI bv
Coronary Artery Disease
Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice
This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting.
- Trial name
- ADVANCE-EU (NCT02060682)
- Testing
- Navvus Catheter FFR
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 60 people
- Sponsor
- Acist Medical Systems
Coronary Artery Disease, Cardiovascular Diseases
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- FORTRESS (NCT03405506)
- Testing
- Quantitative Flow Ratio (QFR)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Coronary Artery Disease
Multislice Computed Tomography Assessment of PCSK9 Inhibition on Coronary Perfusion
The MARKOV study is an investigator-sponsored single arm, prospective study to assess the effect of evolocumab on the improvement in coronary flow (FFRCT) after 18 and 36 months of treatment in patients with coronary…
- Trial name
- MARKOV (NCT03851263)
- Testing
- Evolocumab
- Sponsor
- ECRI bv
Coronary Artery Disease
Vascular Evaluation for Revascularization: Defining the Indications for Coronary Therapy: A Pilot Study
The present prospective, multicenter study will therefore be performed with the primary objective of establishing the correlation between fractional flow reserve (FFR) and intravascular ultrasound with virtual histology…
- Trial name
- VERDICT (NCT01158053)
- Testing
- FFR and VH-IVUS, IVUS and FFR
- Volunteers
- 291 people
- Sponsor
- Volcano Corporation
Coronary Artery Disease
Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease
The use of intra coronary physiological assessment with fractional flow reserve (FFR) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with…
- Trial name
- NCT04679805
- Where
- United Arab Emirates
- Volunteers
- 3 people
- Sponsor
- Ceric Sàrl
Coronary Artery Disease, Coronary Disease
Sensor-equipped Ultrathin Pressure Microcatheter Versus Pressure Wire for Physiological Measurements
TruePhysio pressure microcatheter is a novel device for evaluating the functional significance of coronary stenosis, and its safety and efficacy on the measurement of hyperemic index have been validated in the previous SUPREME…
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- Trial name
- SUPREME II (NCT05417763)
- Testing
- Randomized physiological measurements by the two systems
- Where
- 11 sites in China
- Volunteers
- 487 people
- Sponsor
- Insight Lifetech Co., Ltd.
Coronary Artery Disease
Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography
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…
- Trial name
- DeFACTO (NCT01233518)
- Testing
- FFR
- Where
- United States
- Volunteers
- 285 people
- Sponsor
- HeartFlow, Inc.
Coronary Artery Disease
Evaluation of Health Economics for Noninvasive Coronary Fractional Flow Reserve Measurement Technology
To determine whether, in a Chinese population of patients presenting to Wuhan Asia Heart Hospital, Fractional Flow Reserve Derived from Coronary Computed Tomography Angiography (CT-FFR) as a default test is noninferior in terms…
- Trial name
- NCT05593120
- Testing
- CT-FFR, Routine care
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Coronary Artery Disease
Observational Study of OCT in a Patients Undergoing FFR
The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.
- Trial name
- ILUMIEN I (NCT01663896)
- Testing
- OCT stent guidance
- Where
- 36 sites in United States, Australia and 12 more
- Volunteers
- 418 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy
This is a multi-center, prospective registry of patients with intermediate coronary lesions defined as a stenosis of 40-80% by angiography.
- Trial name
- FIRST (NCT01153555)
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Volcano Corporation
Coronary Artery Disease
HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography
To determine the diagnostic performance of FFRCT by coronary computed tomographic angiography (cCTA), as compared to cCTA alone, for non-invasive determination of the presence of a hemodynamically significant coronary lesion…
- Trial name
- HFNXT (NCT01757678)
- Testing
- ICA (Invasive Coronary Angiography), FFR (Fractional Flow Reserve), cCTA (coronary computed tomography angiography)
- Where
- Denmark
- Volunteers
- 276 people
- Sponsor
- HeartFlow, Inc.
Coronary Artery Disease
An Investigation to Evaluate an Over-The-Wire FFR Infusion Microcatheter (HYPEREM™IC) for Measuring Fractional Flow Reserve (FFR)
This is a single-blinded, randomised, crossover investigation comparing the investigational device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV) infusion method used for obtaining FFR…
- Trial name
- NCT02527616
- Testing
- FFR Infusion Microcatheter and standard intra-venous (IV) infusion
- Where
- United Kingdom
- Volunteers
- 41 people
- Sponsor
- Diasolve Ltd
Coronary Artery Disease, Heart Diseases
Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Coronary angiography-derived FFR assessment (AngioQFA) is a novel technique for physiological lesion assessment based on 3-dimensional (3D) quantitative coronary angiography (QCA) and virtual hyperemic flow derived from contrast…
- Conditions
- Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT06039748
- Testing
- AngioQFA
- Where
- 5 sites in China
- Volunteers
- 330 people
- Sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Coronary Artery Disease (CAD)
Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD
The diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD…
- Trial name
- NCT05885841
- Testing
- XTR004
- Where
- 2 sites in China
- Volunteers
- 83 people
- Sponsor
- Sinotau Pharmaceutical Group
Coronary Stenosis
The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis
The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy…
- Trial name
- NCT04569669
- Testing
- FFR and FFRCT
- Where
- 8 sites in China
- Volunteers
- 325 people
- Sponsor
- CCRF Inc., Beijing, China