Clinical trials: High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Ischemic Heart Disease, Coronary Artery Disease
Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE)
The aim of the SMART-CARE trial is to compare clinical outcomes between coronary CT angiography (CCTA) versus standard care as follow-up strategies in high-risk patients after percutaneous coronary intervention (PCI).
- Trial name
- SMART-CARE (NCT07009418)
- Testing
- Coronary CT Angiography (CCTA)
- Where
- 22 sites in South Korea
- Volunteers
- 3,500 people
- Sponsor
- Samsung Medical Center
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
Myocardial Infarction
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction
Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks.
- Trial name
- Dan-DAPT (NCT05262803)
- Testing
- CYP2C19*2/*3, Shorter DAPT duration
- Where
- 6 sites in Denmark
- Volunteers
- 2,808 people
- Sponsor
- Rikke Sorensen
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.
PCI, Coronary Arterial Disease (CAD)
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing…
- Conditions
- PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
- Trial name
- Shape (NCT07093788)
- Testing
- super high-pressure balloon, intravascular lithotripsy (IVL)
- Where
- 3 sites in China
- Volunteers
- 78 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Acute Coronary Syndrome (ACS), High On-treatment Platelet Reactivity (HTPR)
The Effect of IV Cangrelor and Oral Ticagrelor Study
Major heart attacks are caused by a number of factors, the two major of which are furring up of a coronary artery with atheroma and then sudden clot formation on this area leading to a blockage and interruption of blood flow.
- Conditions
- Acute Coronary Syndrome (ACS), High On-treatment Platelet Reactivity (HTPR), Microvascular Obstruction (MVO), ST-segment Elevation Myocardial Infarction (STEMI)
- Trial name
- NCT02733341
- Testing
- Cangrelor, Ticagrelor
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
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
IHD, LV Dysfunction
Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients
Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease.
- Trial name
- NCT05534698
- Testing
- PCI, CABG
- Where
- Denmark
- Volunteers
- 1,550 people
- Sponsor
- Danish Study Group
Cardiogenic Shock, PCI Patients
Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI.
- Conditions
- Cardiogenic Shock, PCI Patients, Mechanical Circulatory Support
- Trial name
- IMMERGE (NCT06690567)
- Testing
- Impella implantation
- Where
- Italy
- Volunteers
- 700 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no specific intervention in selected elderly patients (60-80 years old) with residual inflammatory risk (hs-CRP≥ 2mg/L) and multivessel…
- Conditions
- Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease, Elderly Patients, C-Reactive Protein
- Trial name
- RIGHT (NCT06025071)
- Testing
- colchicine
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
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
Platelet Reactivity
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting.
- Trial name
- NCT01463150
- Testing
- Clopidogrel, Prasugrel
- Where
- Greece
- Volunteers
- 27 people
- Sponsor
- University of Patras
Acute Coronary Syndrome, Interventional Cardiology
Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events…
- Trial name
- LD-ASPIRIN (NCT04240834)
- Testing
- Aspirin, Ticagrelor
- Where
- China
- Volunteers
- 1,220 people
- Sponsor
- Fu Wai Hospital, Beijing, China
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