Clinical trials: Coronary Artery Stenosis
Myocardial Ischemia, Myocardial Viability
Assessment of Lesion-Associated Myocardial Ischemia Based on Fusion Coronary CT Imaging
The aim of the Fused-Heart study is to investigate the impact of a coronary artery stenosis on myocardial function and viability, based on advanced fusion imaging techniques derived from CCTA.
- Conditions
- Myocardial Ischemia, Myocardial Viability, Coronary Stenosis, Vulnerable Coronary Plaques
- Trial name
- FUSE-HEART (NCT04680689)
- Testing
- 128 Multislice CT coronary angiography, 2D Cardiac Transthoracic Echocardiography, Laboratory Blood tests
- Where
- Romania
- Volunteers
- 100 people
- Sponsor
- Cardio Med Medical Center
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Coronary Restenosis
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of…
- Conditions
- Coronary Artery Disease, Coronary Restenosis, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Trial name
- AGENT-ISR (NCT02151812)
- Testing
- Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon
- Where
- 12 sites in France, Germany
- Volunteers
- 123 people
- Sponsor
- Hemoteq AG
Coronary Artery Disease
First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis
Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal.
- Trial name
- NCT02236975
- Testing
- BuMA Supreme Biodegradable drug coating coronary stent system, Resolute Integrity durable polymer stent system
- Where
- 12 sites in Belgium, Netherlands and 2 more
- Volunteers
- 168 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Coronary Artery Disease
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
- Trial name
- BABILON (NCT01278186)
- Testing
- Balloon angioplasty, Stent implantation
- Where
- 9 sites in Spain
- Volunteers
- 190 people
- Sponsor
- B.Braun Surgical SA
Coronary Stenosis
Physio-Anatomy Clinical Data Collection Study
This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product…
- Trial name
- NCT05312164
- Testing
- HF-OCT Imaging, FFR Pressure Wire, Angiography
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Gentuity, LLC
Coronary Stenosis
BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure.
- Trial name
- NCT03702608
- Testing
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Medinol Ltd.
Coronary Artery Disease
Treatment of Coronary De-novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter
To examine the treatment of coronary de-novo stenosis with a sirolimus coated balloon versus a paclitaxel coated balloon
- Trial name
- SCBDENOVO (NCT03908450)
- Testing
- PTCA of coronary de novo lesion PCB, PTCA of coronary de novo lesion SCB
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 70 people
- Sponsor
- InnoRa GmbH
Coronary Artery Disease, Everolimus
SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial. Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK…
- Conditions
- Coronary Artery Disease, Everolimus, Vascular Disease, Myocardial Ischemia
- Trial name
- NCT00180453
- Testing
- Coronary artery drug eluting stent placement, Coronary artery stent placement
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN Sub-study
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01182428
- Testing
- XIENCE V®/ XIENCE PRIME™, CYPHER SELECT
- Where
- 25 sites in Argentina, Austria and 13 more
- Volunteers
- 455 people
- Sponsor
- Abbott Medical Devices
Coronary Restenosis
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
The objective of this study is to evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System as compared to brachytherapy in patients experiencing in-stent restenosis.
- Trial name
- TAXUS V ISR (NCT00287573)
- Testing
- TAXUS Express2, Brachytherapy (beta source)
- Where
- 42 sites in United States, Canada
- Volunteers
- 488 people
- Sponsor
- Boston Scientific Corporation
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, 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, Coronary Artery Stenosis
Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)
BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
- Trial name
- BIOSOLVE-III (NCT02716220)
- Testing
- Percutaneous Coronary Intervention
- Where
- 8 sites in Belgium, Germany and 2 more
- Volunteers
- 61 people
- Sponsor
- Biotronik AG