Clinical trials: High Risk Percutaneous Coronary Interventions
High-Risk Percutaneous Coronary Intervention
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or…
- Trial name
- NCT05334784
- Testing
- Impella ECP
- Where
- 32 sites in United States
- Volunteers
- 856 people
- Sponsor
- Abiomed Inc.
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage…
- Trial name
- NCT07053618
- Testing
- Implantation of the VADLINK Percutaneous Left Ventricular Assist Device, VA-ECMO
- Where
- 15 sites in China
- Volunteers
- 286 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Acute Coronary Syndrome, Myocardial Infarction
Point of Care (POC) Biomarkers of Ischemia
Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by significant coronary artery disease on cardiac catheterization/revascularization or reversible defect seen on stress test.
- Trial name
- NCT02039882
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Virginia Commonwealth University
Acute Coronary Syndrome
High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay
High on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy.
- Trial name
- HOPEmultiPFA (NCT02699008)
- Testing
- Clopidogrel, Ticagrelor
- Where
- China
- Volunteers
- 477 people
- Sponsor
- Wuhan Asia Heart Hospital
Acute Coronary Syndrome, Type 2 Diabetes
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to "open" coronary…
- Trial name
- NCT00320502
- Testing
- BXT-51072
- Where
- 4 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Synvista Therapeutics, Inc
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
Coronary Artery Disease
Ticagrelor Versus High-dose Clopidogrel in Patients With High Platelet Reactivity on Clopidogrel After PCI
To determine the safety and efficacy of Ticagrelor versus Clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary…
- Trial name
- PL-PLATELET (NCT03078465)
- Testing
- Ticagrelor, Clopidogrel
- Where
- China
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Coronary Artery Disease
Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death.
- Trial name
- spirit (NCT01371058)
- Testing
- high maintenance clopidogrel, routine dual antiplatelet, policosanol plus dual antiplatelet
- Where
- China
- Volunteers
- 350 people
- Sponsor
- Shenyang Northern Hospital
High-Risk Percutaneous Coronary Intervention
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk…
- Trial name
- ELEVATE I (NCT06099548)
- Testing
- The Elevate™ System
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- Magenta Medical Ltd.
Chronic Total Occlusion of Coronary Artery, Angina Pectoris
Invest-CTO PCI Trial
Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Angina Pectoris, Quality of Life, PROM
- Trial name
- NCT04774913
- Testing
- Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)
- Where
- 5 sites in United States, Norway and 1 more
- Volunteers
- 200 people
- Sponsor
- Haukeland University Hospital
Coronary Artery Disease (CAD), Acute Coronary Syndrome (ACS)
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients 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
- NCT01109784
- Testing
- prasugrel, clopidogrel
- Where
- Greece
- Volunteers
- 70 people
- Sponsor
- University of Patras
Myocardial Infarction, Statin Adverse Reaction
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.
- Conditions
- Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity
- Trial name
- ROSUZET-AMI (NCT04499859)
- Testing
- Ezetimibe 10mg + Rosuvastatin 5mg, Rosuvastatin 20mg
- Where
- 7 sites in South Korea
- Volunteers
- 3,548 people
- Sponsor
- Kiyuk Chang, MD,PhD
Coronary Artery Disease, DES
A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial
We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding…
- Trial name
- NCT03947229
- Testing
- Clopidogrel mono-therapy, Dual-antiplatelet therapy
- Where
- South Korea
- Volunteers
- 3,200 people
- Sponsor
- Yonsei University
Coronary Artery Disease, Percutaneous Coronary Intervention
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Myocardial Infarction
- Trial name
- PROTECT-HBR (NCT04416581)
- Testing
- PPI, P-CAB 50
- Where
- 45 sites in South Korea
- Volunteers
- 3,320 people
- Sponsor
- Duk-Woo Park, MD
Acute Myocardial Infarction
Inspiratory Muscle Training in Patients With Acute Myocardial Infarction
Pneumonia is uncommon high among patients with acute myocardial infarction (AMI), which increases adverse clinical events and prolongs the hospital stay.
- Trial name
- NCT04491760
- Testing
- Inspiratory Muscle Training
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Guangdong Provincial People's Hospital
Myocardial Infarction, Angioplasty
Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)
Although statin prior to PCI has favorable effects in stable angina and ACS except ST elevation MI (STEMI), there have been few studies for STEMI. Celik T et al.
- Conditions
- Myocardial Infarction, Angioplasty, Percutaneous Coronary
- Trial name
- STATIN STEMI (NCT00808717)
- Testing
- Atorvastatin
- Where
- South Korea
- Volunteers
- 170 people
- Sponsor
- Yonsei University
CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease
Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI
To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI.
- Conditions
- CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease, Acute Coronary Syndrome, Adrenergic Receptor Antagonist Adverse Reaction
- Trial name
- NCT06286059
- Testing
- Phentolamine
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Helwan University
Acute Coronary Syndrome, High Bleeding Risk
LEADERS FREE II: BioFreedom™ Pivotal Study
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
- Trial name
- NCT02843633
- Testing
- BioFreedom™ Drug Coated Coronary Stent System, Antiplatelet Drug
- Where
- 66 sites in United States, Canada and 5 more
- Volunteers
- 1,203 people
- Sponsor
- Biosensors Europe SA
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
ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI)
Clinical Characteristics, Frailty, and Prognostic Predictors in Patients Aged 75 and Older With Acute Coronary Syndrome
This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS).
- Conditions
- ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina Pectoris
- Trial name
- NCT07366684
- Testing
- Percutaneous Coronary Intervention (PCI), Conservative Medical Therapy
- Where
- Serbia
- Volunteers
- 550 people
- Sponsor
- Clinical Center Niš