Clinical trials: Fractional Flow Reserve, Myocardial
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
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 (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 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
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
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, 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
Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated.
- Trial name
- ACIST-FFR (NCT02577484)
- Testing
- RXi System, Pressure Wire
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Acist Medical Systems
Coronary Artery Disease, Stable Angina
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
- Trial name
- NCT07763769
- Testing
- MedHub AutocathFFR
- Where
- 4 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medhub Ltd.
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
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(CAD)
Comparison of Diagnostic Accuracy Between XTR004 PET MPI and the Composite Index of Quantitative Coronary Angiography (QCA) and Fractional Flow Reserve (FFR)
The primary objective of this study is to evaluate the effectiveness of visual reading in XTR004 PET myocardial perfusion imaging (MPI) for detecting restrictive stenosis, using quantitative coronary angiography (QCA) and…
- Trial name
- NCT07439133
- Testing
- XTR004
- Where
- 5 sites in China
- Volunteers
- 395 people
- Sponsor
- Sinotau Pharmaceutical Group
Coronary Artery Diseases, Multivessel Coronary Artery Disease
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in…
- Conditions
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- SYNTAX III (NCT02813473)
- Testing
- Coronary Angiography, Computed Tomography (CT) scan
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 223 people
- Sponsor
- ECRI bv
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 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, Coronary Stenosis
FUnctional diagnoSIs of corONary Stenosis (FUSION)
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
- Trial name
- FUSION (NCT04356027)
- Testing
- ICA (Invasive Coronary Angiography), OCT, FFR
- Where
- 28 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
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
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 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
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