Clinical trials: High Risk PCI
Coronary Artery Disease, Coronary Disease
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary…
- Conditions
- Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases
- Trial name
- ROSUVA-30 (NCT02859480)
- Testing
- Rosuvastatin 5mg, Rosuvastatin 20mg
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Korea University Anam Hospital
High-risk Percutaneous Coronary Intervention
Impella ECP Early Feasibility Study
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
- Trial name
- ECP EFS (NCT04477603)
- Testing
- Impella ECP
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
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
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
Chronic Coronary Syndrome, Acute Coronary Syndromes
Optimal LDL-C Target in High-risk Patients After PCI
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and…
- Conditions
- Chronic Coronary Syndrome, Acute Coronary Syndromes, Percutaneous Coronary Intervention, High Risk Patient
- Trial name
- REC-SAFETARGET (NCT06821711)
- Testing
- Intensive LDL-C control, Conventional LDL-C control
- Where
- China
- Volunteers
- 12,000 people
- Sponsor
- Xijing Hospital
Left Ventricular Dysfunction, Coronary Artery Disease
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health…
- Trial name
- PROTECT IV (NCT04763200)
- Testing
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Where
- 110 sites in United States, Canada and 5 more
- Volunteers
- 1,252 people
- Sponsor
- Abiomed Inc.
ECMO, High-risk PCI
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI).
- Trial name
- ECMO-READY (NCT06274411)
- Testing
- Standby cannulated ECMO, Prophylactic ECMO
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients…
- Trial name
- STRATUS-PCI (NCT07588399)
- Testing
- Impella CP
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Rayyan Hemetsberger
Coronary Artery Disease
The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg)…
- Trial name
- NCT00407771
- Testing
- Tirofiban
- Where
- Jordan
- Volunteers
- 44 people
- Sponsor
- Jordan 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
ST-segment Elevation Myocardial Infarction (STEMI)
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy
This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis.
- Trial name
- BRIGHT-FIT (NCT06861374)
- Testing
- Bivalirudin, Unfractionated heparin
- Volunteers
- 2,400 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
ST Elevation Myocardial Infarction (STEMI), Malondialdehyde
Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial
This study aims to evaluate whether supplementation with a combination of curcumin and piperine can help reduce inflammation and oxidative stress in patients who have experienced a heart attack called ST-Elevation Myocardial…
- Conditions
- ST Elevation Myocardial Infarction (STEMI), Malondialdehyde, Hs-CRP, Curcumin
- Trial name
- SPICE STEMI (NCT07149961)
- Testing
- Curcumin plus Piperine
- Where
- Indonesia
- Volunteers
- 50 people
- Sponsor
- Universitas Diponegoro
Atrial Fibrillation, Coronary Artery Disease
Antithrombotic Strategy for AF Patients With High Risk CAD
Anticoagulation therapy is recommended for patients with atrial fibrillation (AF) in order to prevent ischemic stroke and systemic embolism.
- Trial name
- ADAPT AFFIRM (NCT06866665)
- Testing
- Anticoagulation Monotherapy, Combination therapy
- Volunteers
- 1,400 people
- Sponsor
- Yonsei University
Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial
This study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary…
- Trial name
- NCT05782777
- Testing
- ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg), high-intensity statin monotherapy (atoravastatin 40mg)
- Where
- South Korea
- Volunteers
- 4,310 people
- Sponsor
- Yonsei University
ST Elevation Myocardial Infarction
Remote Ischemic Conditioning With Local Ischemic Postconditioning in High-Risk ST-elevation Myocardial Infarction
The RIP-HIGH trial is a two-arm randomized controlled trial aiming to compare the impact of combined remote ischemic conditioning (RIP) and local ischemic postconditioning (PostC) vs.
- Trial name
- RIP-HIGH (NCT04844931)
- Testing
- RIC + PostC + Standard PCI, Standard PCI
- Where
- 11 sites in Austria, Germany
- Volunteers
- 250 people
- Sponsor
- Helios Health Institute GmbH
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
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
High-risk PCI
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing…
- Trial name
- NCT07860671
- Testing
- NyokAssist, ECMO
- Where
- 14 sites in China
- Volunteers
- 204 people
- Sponsor
- magAssist, Inc.
Shock, Cardiogenic, High Risk Percutaneous Coronary Interventions
Synchronized Cardiac Assist for Cardiogenic Shock
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous…
- Trial name
- NCT02697006
- Testing
- i-cor Synchronized Cardiac Assist Device
- Where
- Germany
- Volunteers
- 47 people
- Sponsor
- Xenios AG
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