Clinical trials: Coronary Artery Lesion
Coronary Artery Disease, Coronary Atherosclerosis
Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for…
- Trial name
- ELITE (NCT00715884)
- Testing
- CYPHER® ELITE™ Sirolimus-Eluting Stent System, CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
- Where
- United States
- Volunteers
- 678 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.
- Trial name
- PLATINUM PK (NCT01510327)
- Testing
- PROMUS Element Everolimus-Eluting Coronary Stent System, Aspirin, Thienopyridine
- Where
- 5 sites in United States, Japan
- Volunteers
- 22 people
- Sponsor
- Boston Scientific Corporation
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of…
- Trial name
- ENDEAVORSVS (NCT00609947)
- Testing
- Endeavor Zotarolimus-Eluting Coronary Stent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Vascular
Coronary Artery Bypass
Microparticles in Stored RBC as Potential Mediators of Transfusion Complications
INTRODUCTION. Cell-derived microparticles (MP) are released in cell activation, apoptosis and other processes. MP derived from red cells (RMP) are known to be released from stored packed red blood cells (PRBC), and their number…
- Trial name
- NCT01185600
- Testing
- Washed RBC, Unwashed RBC
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- University of Miami
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort B
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB B (NCT00856856)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 12 sites in Australia, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Coronary Artery Disease
The ROB-OSTIAL Study
The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions.
- Trial name
- NCT05634538
- Testing
- Robotic-assisted PCI with Corpath GRX® System, Standard PCI
- Where
- Italy
- Volunteers
- 1 people
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
de Novo Stenotic Lesions in Native Coronary Arteries
NIRTRAKS Post-Market Study (NIRTRAKS)
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical study that will be conducted at up to 15 sites in the United States (US).
- Trial name
- NIRTRAKS (NCT02455804)
- Testing
- Stenting procedure
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medinol Ltd.
Stable Angina, Heart Failure
Plasmonic Nanophotothermal Therapy of Atherosclerosis
The investigators hypothesize that the nanoburning is a very challenging technique to demolish and reverse the plaque especially in combination with stem cell technologies promising the functional restoration of the vessel wall.
- Conditions
- Stable Angina, Heart Failure, Atherosclerosis, Multivessel Coronary Artery Disease
- Trial name
- NANOM-FIM (NCT01270139)
- Testing
- Transplantation of nanoparticles, Transplantation of iron-bearing nanoparticles, Stenting
- Where
- 4 sites in Netherlands, Russia
- Volunteers
- 180 people
- Sponsor
- Ural State Medical University
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Arterial Occlusion, Cardiovascular Diseases
Comparing TR Band to Statseal in Conjunction With TR Band II
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- Statseal II (NCT04046952)
- Testing
- Statseal with TR Band, TR band only
- Where
- United States
- Volunteers
- 443 people
- Sponsor
- VA Long Beach Healthcare System
Coronary Artery Lesions
XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary…
- Trial name
- NCT03218787
- Testing
- XIENCE, DAPT
- Where
- 101 sites in United States
- Volunteers
- 2,047 people
- Sponsor
- Abbott Medical Devices
Atherosclerosis, Coronary Artery Disease
Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery…
- Trial name
- PTChina (NCT01285999)
- Testing
- PROMUS Element Coronary Stent System, TAXUS Liberté Coronary Stent System
- Where
- 15 sites in China
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Abbott Next Generation Drug Eluting Stent 48mm Study
The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary…
- Trial name
- SPIRIT 48 (NCT04282148)
- Testing
- ABT NG DES 48 EECSS
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Coronary Arteries Disease
BIOHELIX-I Bare Metal Stent Study
The purpose of this study is to demonstrate the safety and efficacy of the investigational BIOTRONIK PRO-Kinetic Energy stent in subjects with atherosclerotic disease of native coronary arteries.
- Trial name
- BIOHELIX-I (NCT01612767)
- Testing
- PRO-Kinetic Energy Stent
- Where
- 35 sites in United States, Colombia and 3 more
- Volunteers
- 329 people
- Sponsor
- Biotronik, Inc.
Coronary Artery Disease
DESyne X2 Post Market Follow-up Study
A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.
- Trial name
- NCT04375085
- Testing
- Percutaneous Coronary Intervention
- Where
- 3 sites in China
- Volunteers
- 49 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity…
- Trial name
- RI-US (NCT01638507)
- Testing
- Resolute Integrity Stent
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- Medtronic Vascular
Chronic Total Occlusion of Coronary Artery, Coronary Occlusion
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01759290
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- Belgium
- Volunteers
- 1,800 people
- Sponsor
- Abbott Medical Devices