Clinical trials: High Risk Percutaneous Coronary Interventions
Coronary Artery Disease, Percutaneous Coronary Intervention
Adjunctive Cilostazol Versus High Maintenance-dose Clopidogrel According to Cytochrome 2C19 Polymorphism
The purpose of this study is to determine the impact of adjunctive cilostazol versus high maintenance-dose clopidogrel on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 mutant allele.
- Trial name
- ACCEL-2C19 (NCT01012193)
- Testing
- cilostazol 100mg bid or clopidogrel 150-mg daily
- Where
- South Korea
- Volunteers
- 134 people
- Sponsor
- Gyeongsang National University Hospital
Coronary Artery Disease
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)
- Trial name
- Vortex-FIH (NCT04674111)
- Testing
- Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
- Where
- 2 sites in Australia, Sweden
- Volunteers
- 5 people
- Sponsor
- Boston Scientific Corporation
High Risk Percutaneous Coronary Intervention
HeartMate PHP™ CE Mark Clinical Investigation Plan
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable…
- Trial name
- HM PHP CE Mark (NCT02156609)
- Testing
- Percutaneous ventricular support with the HeartMate PHP
- Where
- 7 sites in Colombia, Netherlands and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Phitys I™ Percutaneous Left Ventricular Assist System Study
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
- Trial name
- NCT06357026
- Testing
- Percutaneous Ventricular Assist System（Phigine Medical）, intra-aortic balloon pump (IABP)
- Where
- 8 sites in China
- Volunteers
- 344 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Acute Coronary Syndrome, ST Elevation Myocardial Infarction
Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI
This is an multicenter, randomized, controlled, parallel group study. ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(HTB) will be allocated to one of the following: intrathrombus…
- Conditions
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention
- Trial name
- ATTRACTIVE (NCT05554588)
- Testing
- Intrathrombus Thrombolysis During Primary PCI, Aspiration Thrombectomy During Primary PCI
- Where
- China
- Volunteers
- 2,500 people
- Sponsor
- China-Japan Friendship Hospital
Coronary Artery Disease
Ranolazine Loading to Prevent PCI-induced Myocardial Injury
It has previously been shown that pretreatment with ranolazine 1,000 mg twice daily for 7 days can significantly reduce procedural myocardial injury in elective percutaneous coronary intervention (PCI).
- Trial name
- TWILIGHT (NCT01491061)
- Testing
- Ranolazine
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
Coronary Artery Disease (CAD)
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting…
- Trial name
- TRIGGER-PCI (NCT00910299)
- Testing
- Prasugrel, Clopidogrel
- Where
- 27 sites in United States, Germany
- Volunteers
- 423 people
- Sponsor
- Eli Lilly and Company
Heart Disease, Coronary Arterial Disease (CAD)
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular…
- Conditions
- Heart Disease, Coronary Arterial Disease (CAD), Heart Failure
- Trial name
- NCT07407816
- Testing
- Supira System
- Where
- 2 sites in Georgia
- Volunteers
- 45 people
- Sponsor
- Supira Medical
Bleeding Disorder, Ischemic Stroke
XIENCE 28 USA Study
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR)…
- Conditions
- Bleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases
- Trial name
- NCT03815175
- Testing
- XIENCE, DAPT (aspirin and/or P2Y12 receptor inhibitor)
- Where
- 111 sites in United States, Austria and 13 more
- Volunteers
- 1,605 people
- Sponsor
- Abbott Medical Devices
Renal Insufficiency, Chronic, Coronary Angiography
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem.
- Conditions
- Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
- Trial name
- NCT00345501
- Testing
- Iloprost
- Where
- Greece
- Volunteers
- 208 people
- Sponsor
- Onassis Cardiac Surgery Centre
High Bleeding Risk, Coronary Artery Disease (CAD)
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing…
- Conditions
- High Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
- Trial name
- DEBORA (NCT04885816)
- Testing
- Drug Eluting Balloon (DEB), Drug Eluting Stents (DES)
- Where
- Mexico
- Volunteers
- 5 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction
Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease
Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD.
- Conditions
- Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction, Angina (Stable), Unstable Angina Pectoris
- Trial name
- ENDO-R (NCT06788275)
- Testing
- Aerobic exercise (MIT), Aerobic exercise (Short HIIT), Aerobic exercise (Long HIIT)
- Where
- 2 sites in Spain
- Volunteers
- 132 people
- Sponsor
- Instituto de Investigación Sanitaria y Biomédica de Alicante
Coronary Artery Disease With Myocardial Infarction
Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention
The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy…
- Trial name
- POST PCI (NCT03217877)
- Testing
- routine stress testing, No Routine stress testing
- Where
- 11 sites in South Korea
- Volunteers
- 1,700 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease, Heart Failure
PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI
To determine whether hemodynamic support combining VA-ECMO with IABP could mitigate the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs), compared with IABP support alone, in patients undergoing elective…
- Trial name
- NCT04045873
- Testing
- extracorporeal membrane oxygenation
- Volunteers
- 306 people
- Sponsor
- Xijing Hospital
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Bleeding, Coronary Artery Disease
Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry
The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor…
- Conditions
- Bleeding, Coronary Artery Disease, Myocardial Infarction
- Trial name
- ICARUS (NCT05505591)
- Testing
- Cangrelor
- Where
- 2 sites in Italy
- Volunteers
- 900 people
- Sponsor
- Universita degli Studi di Genova
Percutaneous Coronary Intervention, High Bleeding Risk
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Background. Randomized data on the optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) are lacking. Methods.
- Conditions
- Percutaneous Coronary Intervention, High Bleeding Risk, Acute Coronary Syndromes, Anticoagulant Therapy
- Trial name
- BRIGHT-HBR (NCT07383155)
- Testing
- Anticoagulant Therapy
- Volunteers
- 5,270 people
- Sponsor
- Shenyang Northern Hospital
Platelet Reactivity
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI.
- Trial name
- NCT01835353
- Testing
- Prasugrel 100mg loading dose, Prasugrel 60mg loading dose
- Where
- Greece
- Volunteers
- 82 people
- Sponsor
- University of Patras
Acute Myocardial Infarction, Percutaneous Coronary Intervention
CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)
This study is intended to provide contemporary data on the residual cardiovascular risk in all consecutive patients with acute myocardial infarction, especially in patients who survived stably within one-year after percutaneous…
- Conditions
- Acute Myocardial Infarction, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events, Bleeding
- Trial name
- NCT02806102
- Testing
- Percutaneous coronary intervention, Dual-antiplatelet therapy
- Where
- 2 sites in South Korea
- Volunteers
- 13,000 people
- Sponsor
- Seoul St. Mary's Hospital
Ischemic Heart Disease, Coronary Artery Disease
Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a…
- Trial name
- CHIP-BCIS3 (NCT05003817)
- Testing
- Percutaneous left ventricular unloading
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust