Clinical trials: High-Risk Percutaneous Coronary Intervention, open to volunteers
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
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
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
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
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
Coronary Artery Disease
Phimume® 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 extracorporeal membrane oxygenation (ECMO) for circulatory support during high-risk PCI.
- Trial name
- NCT06639321
- Testing
- Percutaneous Ventricular Assist System, extracorporeal membrane oxygenation (ECMO)
- Where
- 6 sites in China
- Volunteers
- 250 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Coronary Disease, Heart Diseases
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
ST-segment Elevation Myocardial Infarction (STEMI)
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included.
- Trial name
- NCT04212494
- Testing
- Thrombus aspiration, PCI Alone
- Where
- 50 sites in China
- Volunteers
- 3,838 people
- Sponsor
- Guangdong Provincial People's Hospital
Acute Myocardial Infarction, Heart Failure
Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and…
- Trial name
- PRESTIGE-AMI (NCT04899479)
- Testing
- SGLT2 inhibitor, Control
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
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
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
A Precision Medicine Approach to Identify Patients Undergoing Elective PCI at Risk of Peri-PCI Myocardial Infarction
Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI, occurring in up to 30% of patients.
- Trial name
- NCT05332262
- Testing
- Assessment of platelet reactivity, Troponin measurement
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- University of Florida
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
Livalozet Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Acute myocardial infarction is one of the leading causes of death in elderly patients, and the importance of lipid-lowering therapy as a secondary prevention strategy to reduce cardiovascular events is emphasized.
- Trial name
- SMARTDECISION2 (NCT07626840)
- Testing
- Pitavastatin/ezetimibe, Atorvastatin or Rosuvastatin
- Volunteers
- 5,000 people
- Sponsor
- Samsung Medical Center
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
Acute Coronary Syndrome
DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid
Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at…
- Trial name
- BETA-DAPT (NCT07391358)
- Testing
- Patient decision aid to support shared decision-making between patients and clinicians
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Montreal Heart Institute
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
Coronary Artery Disease, Dyslipidemias
Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention
[Purpose of the Clinical Study]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to…
- Conditions
- Coronary Artery Disease, Dyslipidemias, Primary Prevention
- Trial name
- ALMIGHTY (NCT06186037)
- Testing
- Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg, Mono drug group of Rosuvastatin 20 mg
- Where
- South Korea
- Volunteers
- 6,356 people
- Sponsor
- Saint Vincent's Hospital, Korea
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the…
- Trial name
- NCT07025148
- Testing
- Prasugrel, Clopidogrel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida
Coronary Artery Disease, Ischemic Heart Disease
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding.
- Trial name
- ACO_FLEX (NCT06863155)
- Testing
- Supraflex Cruz Sirolimus-eluting Stent
- Where
- 13 sites in Spain
- Volunteers
- 500 people
- Sponsor
- Fundación EPIC