Clinical trials: High-risk PCI
Complex High-risk and Indicated Patients
Long-term Outcomes of Patients Undergoing ECMO-assisted PCI
Evidence regarding the long-term outcomes of patients undergoing Veno-arterial extracorporeal membrane oxygenator (VA-ECMO) assisted percutaneous coronary intervention (PCI) and the impact of the operator experience is limited.
- Trial name
- NCT06713876
- Testing
- VA-ECMO-assisted PCI
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Ling Tao, MD, PhD
Coronary Artery Disease
Safety of High-dose Tirofiban During Coronary Angioplasty
This single-centre study is intended to retrospectively check the safety of high-dose bolus of tirofiban in patients who underwent percutaneous angioplasty.
- Trial name
- SANTISS (NCT00566891)
- Testing
- tirofiban, Clopidogrel
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- S. Anna Hospital
ST Elevation (STEMI) Myocardial Infarction
High-Dose Rosuvastatin Preloading for Enhanced Outcomes in STEMI Patients Undergoing Primary PCI
To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days
- Trial name
- HEROS-PCI (NCT06924684)
- Testing
- Statin monotherapy (rosuvastatin or atorvastatin)
- Where
- 2 sites in Pakistan
- Volunteers
- 66 people
- Sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
Coronary Artery Disease, Percutaneous Coronary Intervention
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- DAPTLong (NCT06075433)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Ventricular Assist System for PCI in CHIP Patients
In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge.
- Trial name
- REC-CHIPMCS (NCT06373120)
- Testing
- Microaxial flow pump, VA-ECMO
- Where
- China
- Volunteers
- 262 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Acute Coronary Syndromes
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors With Statin for ACS Patients
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD).
- Trial name
- NCT07736313
- Testing
- PCSK9 inhibitor plus rosuvastatin 20 mg tab, Rosuvastatin 20 Mg Oral Tablet
- Volunteers
- 120 people
- Sponsor
- Assiut University
Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention
Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents.
- Trial name
- BEET-CIN (NCT06984406)
- Testing
- Beet-Derived Inorganic Nitrate-Based Food Product
- Where
- Russia
- Volunteers
- 88 people
- Sponsor
- National Medical Research Center for Therapy and Preventive Medicine
Coronary Artery Disease
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more…
- Trial name
- SMART-CHOICE3 (NCT04418479)
- Testing
- Aspirin, Clopidogrel
- Where
- South Korea
- Volunteers
- 5,506 people
- Sponsor
- Joo-Yong Hahn
Cardiogenic Shock, High Risk PCI
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
- Trial name
- NCT05820451
- Testing
- Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution
- Where
- 20 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abiomed Inc.
Ulcerative Colitis
The Contact Activation System and Ulcerative Colitis
The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis. Contact activation system measures are compared in a cross sectional (healthy controls vs.
- Trial name
- NCT04621006
- Testing
- Continuously assessment of disease activity
- Where
- Denmark
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
Myocardial Infarction
Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.
The goal of this is observational study is to compare about MACE events and predisposing factors related to MACE events in elderly patients with high-risk non-ST acute coronary syndromes receiving early versus late invasive…
- Trial name
- NCT06486233
- Where
- Vietnam
- Volunteers
- 385 people
- Sponsor
- Gia Dinh People Hospital
Acute Coronary Syndromes
Impact of Clopidogrel Dose Adjustment According to Platelet Reactivity Monitoring in Patients With High on Treatment Platelet Reactivity Undergoing Percutaneous Coronary Intervention
Acute coronary syndromes are related to the development of a platelet derived thrombus on a ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a significantly reduced the risk of major adverse…
- Trial name
- NCT01505790
- Testing
- PRASUGREL, Clopidogrel
- Where
- France
- Volunteers
- 187 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Coronary Artery Disease
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
- Trial name
- NCT06445608
- Testing
- Percutaneous Mechanical Circulatory Support
- Where
- 18 sites in United States
- Volunteers
- 310 people
- Sponsor
- Kardion Inc
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.
STEMI, Elevated IMR (>32)
A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving…
- Trial name
- RESTORE-MI (NCT03998319)
- Testing
- Tenecteplase (1/3 systemic weight based dose), Sterile water for injection (WFI)
- Where
- 22 sites in Australia, New Zealand
- Volunteers
- 445 people
- Sponsor
- University of Sydney
Coronary Artery Disease
Drug-Coated Balloon in Patients With High Bleeding Risk
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of…
- Trial name
- DCB-HBR (NCT05221931)
- Testing
- Percutaneous coronary intervention
- Where
- 17 sites in South Korea
- Volunteers
- 1,359 people
- Sponsor
- Samsung Medical Center
Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI)
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients.
- Conditions
- Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI), Stable Angina (Associated With High Risk PCI)
- Trial name
- NCT01020383
- Testing
- ALX-0081, ReoPro®
- Where
- 39 sites in Austria, Belgium and 5 more
- Volunteers
- 364 people
- Sponsor
- Ablynx, a Sanofi company
Acute Myocardial Infarction (AMI)
Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction
Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) combined with guideline-directed medical therapy has substantially improved survival…
- Trial name
- COMET-AMI (NCT07537296)
- Testing
- Cardiac CT Follow-up and Echocardiographic Follow-up
- Where
- 2 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Acute Coronary Syndrome
Continuous Clopidogrel Dose Adjustment in Acute Coronary Syndrome Patients With High On-treatment Platelet Reactivity
The purpose of this study is to determine whether continuous clopidogrel dose adjustment targeted after platelet function testing improves outcomes during 12 months of follow-up in acute coronary syndrome patients treated with…
- Trial name
- NCT02096419
- Testing
- Clopidogrel dose adjustment
- Where
- Croatia
- Volunteers
- 87 people
- Sponsor
- University of Zagreb
ST-segment Elevation Myocardial Infarction (STEMI)
Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial
The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function…
- Trial name
- TRAP-MI (NCT07551700)
- Testing
- Manual Thrombus Aspiration, Primary Percutaneous Coronary Intervention (PPCI)
- Volunteers
- 6,760 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University