Clinical trials: High-risk PCI, open to volunteers
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
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
Vascular Calcification
Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions
Study Design Prospective, multicenter, single-blind, randomized controlled trial Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using…
- Trial name
- CRUSH-CALC (NCT07279987)
- Testing
- Super High-Pressure Non-Compliant Balloon, Intravascular Lithotripsy System
- Where
- China
- Volunteers
- 162 people
- Sponsor
- Lin Zhao
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
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
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
Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study
This pilot study aims to evaluate whether a single dose of PCSK9 inhibitor administered after percutaneous coronary intervention (PCI) can improve long-term cardiovascular outcomes in patients with high post-PCI lipid core…
- Trial name
- HANYANG-PICK (NCT07084259)
- Testing
- PCSK9 inhibitor, Standard Lipid-Lowering Therapy
- Volunteers
- 352 people
- Sponsor
- Hanyang University Seoul Hospital
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, 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
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
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, Atherosclerotic Cardiovascular Disease (ASCVD)
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
This multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after…
- Conditions
- Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD), Residual Inflammatory Risk
- Trial name
- NCT07920133
- Testing
- Colchicine (Colcrys®)
- Where
- China
- Volunteers
- 1,768 people
- Sponsor
- Sir Run Run Shaw Hospital
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), High Bleeding Risk
Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR
The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients…
- Trial name
- GUIDE-HBR (NCT06763744)
- Testing
- P2Y12 antagonist monotherapy, clopidogrel + aspirin
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease, Heart Failure
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients…
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Trial name
- NCT06754839
- Testing
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Volunteers
- 250 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Complex Higher Risk Indicated Patients Undergoing PCI
IVUS CHIP China Registry
The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question[s] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients…
- Trial name
- NCT06274645
- Testing
- The OptiCross High Definition (60 MHz) and OptiCross (40MHz) Intravascular Ultrasound (IVUS) catheter from Boston Scientific
- Where
- China
- Volunteers
- 2,020 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Coronary Artery Disease
Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients
Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.
- Trial name
- NCT05923489
- Testing
- Routine Angiography Follow-up, Routine Clinical Follow-up
- Where
- China
- Volunteers
- 2,618 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
Coronary Artery Disease, Coronary Artery Disease Risk High
IVUS CHIP UPP Registry
The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease Risk High, Complex Coronary Artery Disease
- Trial name
- NCT06625801
- Testing
- IVUS
- Where
- 18 sites in United States
- Volunteers
- 1,010 people
- Sponsor
- ECRI bv
Coronary Artery Disease
The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System
This study aims to evaluate the safety and effectiveness of the VentriCure interventional left ventricular assist system for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in…
- Trial name
- NCT07675005
- Testing
- VentriCure Interventional left ventricular assist system, ECMO
- Volunteers
- 220 people
- Sponsor
- Life Shield Medical Technology Co., LTD