Clinical trials: High-risk PCI
Radial Artery Occlusion
Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial.
Double blind single center clinical trial to compare the incidence of radial artery occlusion (RAO) using standard doses of Unfractionated Heparin (UFH) vs. high doses of UFH.
- Trial name
- DEFINITION (NCT04561648)
- Testing
- Unfractionated Heparin
- Where
- Mexico
- Volunteers
- 1,988 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes.
- Conditions
- Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease, Coronary Artery Disease, Cardiogenic Shock
- Trial name
- POTOK (NCT07149714)
- Testing
- iVAC 2L
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Myocardial Infarction
Value of Abciximab in Patients With AMI Undergoing Primary PCI After Clopidogrel Pretreatment (BRAVE 3)
The purpose of this study is to assess whether abciximab is associated with additional benefit in patients with AMI treated with PCI after high dose clopidogrel loading.
- Trial name
- NCT00133250
- Testing
- Abciximab
- Where
- 5 sites in Austria, Germany
- Volunteers
- 800 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Platelet Dysfunction
Evaluation of Platelet Function After Statin Loading Dose in Patients Before Percutaneous Coronary Intervention
The purpose of this study is to evaluate the effect of a loading dose of two different statins on platelet reactivity (atorvastatin, metabolized by CYP3A4, and rosuvastatin, which is rather independent of this enzyme)in patients…
- Trial name
- STATIPLAT (NCT01526460)
- Testing
- Atorvastatin, Rosuvastatin
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- IRCCS San Raffaele
Coronary Artery Disease, Percutaneous Coronary Intervention
Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.
Patients who undergo percutaneous coronary intervention (PCI) are commonly treated with antiplatelet therapy to prevent stent thrombosis and recurrence of events.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes, Antiplatelet Therapy
- Trial name
- HI-TECH 2 (NCT07582835)
- Testing
- Clopidogrel, Ticagrelor, Prasugrel
- Where
- Switzerland
- Volunteers
- 355 people
- Sponsor
- Cardiocentro Ticino
Coronary Artery Disease, Percutaneous Coronary Intervention
Different Doses of Colchicine on hsCRP
Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023.
- Trial name
- NCT06078904
- Testing
- Colchicine 0.5 MG, Colchicine 0.375 MG, Colchicine 0.25 MG
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Coronary Artery Disease
Conventional Versus Intentional StraTegy in Lesions With High Risk PrEdiction of Side Branch OccLusion in InterVEntion
The purpose of the present study is to investigate if intentional strategy (a more aggressive side branch protection strategy: elective two-stent or jailed balloon technique) is associated with significant reduction of side…
- Trial name
- CIT-RESOLVE (NCT02644434)
- Testing
- Conventional Strategy, Intentional strategy
- Where
- China
- Volunteers
- 566 people
- Sponsor
- China National Center for Cardiovascular Diseases
Coronary Artery Disease
Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation
To achieve optimal long-term clinical results after percutaneous coronary intervention (PCI), adequate deployment of stents is essential.
- Trial name
- OPTIMIZE-PCI (NCT06558474)
- Testing
- Liberal post-dilatation strategy during PCI
- Where
- Netherlands
- Volunteers
- 12,000 people
- Sponsor
- Cathreine BV
Coronary Artery Disease
Short-term Outcomes of Elective High-risk PCI With Extracorporeal Membrane Oxygenation Support: a Single-centre Registry
Background Revascularization of complex coronary artery disease, including multivessel coronary artery disease, left main stenosis, bifurcation stenosis and chronic total occlusions (CTO) can be performed by Percutaneous Coronary…
- Trial name
- NCT05387902
- Testing
- Extracorporeal Membrane Oxygenation
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Robert Jan van Geuns
High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
- Trial name
- VITALYST EFS (NCT06132568)
- Testing
- VITALYST System
- Where
- 5 sites in United States, Sweden
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Myocardial Infarction, Acute Coronary Syndromes
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is…
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina
- Trial name
- SAVI-PCI (NCT01522417)
- Testing
- Short Tirofiban, Eptifibatide, Long Tirofiban
- Where
- 13 sites in United States
- Volunteers
- 535 people
- Sponsor
- Medicure
Ischemic Heart Disease, Atrial Fibrillation
Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
- Trial name
- INTERMITTENT (NCT04151680)
- Testing
- Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban, Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
- Where
- 2 sites in Italy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
Coronary Artery Disease
PMCF Study for Cardiology Access Procedures
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the…
- Trial name
- NCT05543096
- Testing
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Where
- 8 sites in Austria, Belgium
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to…
- Trial name
- DEBATE (NCT04814212)
- Testing
- Percutaneous coronary intervention using drug-coated balloon, Percutaneous coronary intervention using drug-eluting stent
- Where
- 14 sites in Finland, France and 2 more
- Volunteers
- 546 people
- Sponsor
- North Karelia Central Hospital
Coronary Artery Disease
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.
- Trial name
- ESTATE (NCT00979940)
- Testing
- Atorvastatin
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
NLRP3, hsCRP
Effect of Inflammasome Inhibitor on hsCRP in Patients After PCI
Coronary artery disease (CAD) comprises the major contributor to a global epidemic of cardiovascular disease. Patients with CAD undergoing percutaneous coronary intervention (PCI) have a high-risk for adverse clinical outcomes.
- Conditions
- NLRP3, hsCRP, Percutaneous Coronary Intervention
- Trial name
- NCT05130892
- Testing
- Colchicine, Tranilast, Oridonin
- Where
- 2 sites in China
- Volunteers
- 132 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary
First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI
Patients will undergo intracoronary imaging using combined optical coherence tomography-fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the…
- Conditions
- Atherosclerosis Coronary Artery With Angina Pectoris, Atheroscleroses, Coronary, Atherosclerotic Plaque, Thin-cap fIbroatheroma
- Trial name
- NCT04835467
- Testing
- Dual-modal OCT-FLIm
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Korea University Guro Hospital
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
Acute Coronary Syndromes
PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants
The investigators hypothesize that reduced loading dose of prasugrel followed by reduced maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism undergoing percutaneous coronary intervention…
- Trial name
- PRAISE-GENE (NCT01641510)
- Testing
- Prasugrel, Clopidogrel
- Where
- South Korea
- Volunteers
- 70 people
- Sponsor
- Dong-A University
Coronary Artery Disease (CAD)
Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging
Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly used and have been extensively studied separately to guide percutaneous coronary intervention and improve long-term outcomes.
- Trial name
- NCT02984891
- Testing
- Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Columbia University