Clinical trials: High Risk PCI
High-risk Percutaneous Coronary Intervention
Impella ECP Early Feasibility Study
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
- Trial name
- ECP EFS (NCT04477603)
- Testing
- Impella ECP
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
ELEVATE High-Risk PCI Pivotal Study
The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group.
- Trial name
- ELEVATE III (NCT07001332)
- Testing
- Elevate, Impella
- Where
- 33 sites in United States
- Volunteers
- 290 people
- Sponsor
- Magenta Medical Ltd.
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.
Coronary Artery Diseases, Multivessel Coronary Artery Disease
SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in…
- Conditions
- Coronary Artery Diseases, Multivessel Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases
- Trial name
- SYNTAX III (NCT02813473)
- Testing
- Coronary Angiography, Computed Tomography (CT) scan
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 223 people
- Sponsor
- ECRI bv
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.
Percutaneous Coronary Intervention, Coronary Artery Disease
Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System
Insight Lifetech Intravascular Ultrasound Diagnostic System (referred to as Insight Lifetech IVUS system below),is a new high-speed and high-resolution device for clearly defining vessel architecture and plaque morphology…
- Conditions
- Percutaneous Coronary Intervention, Coronary Artery Disease, Chronic Total Occlusion of Coronary Artery, Left Main Coronary Artery Disease
- Trial name
- NEW-IVUS (NCT04739657)
- Testing
- Insight Lifetech IVUS System, Boston Scientific IVUS System
- Where
- 5 sites in China
- Volunteers
- 130 people
- Sponsor
- Insight Lifetech Co., Ltd.
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
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.
Coronary Artery Disease (CAD)
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting…
- Trial name
- TRIGGER-PCI (NCT00910299)
- Testing
- Prasugrel, Clopidogrel
- Where
- 27 sites in United States, Germany
- Volunteers
- 423 people
- Sponsor
- Eli Lilly and Company
Coronary Artery Disease
Protect II, A Prospective, Multicenter Randomized Controlled Trial
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
- Trial name
- PROTECT II (NCT00562016)
- Testing
- IMPLELLA LP 2.5, IABP Intra-aortic balloon pump
- Where
- 50 sites in United States, Canada and 1 more
- Volunteers
- 452 people
- Sponsor
- Abiomed 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.
Myocardial Infarction, Acute Coronary Syndromes
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is…
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina
- Trial name
- SAVI-PCI (NCT01522417)
- Testing
- Short Tirofiban, Eptifibatide, Long Tirofiban
- Where
- 13 sites in United States
- Volunteers
- 535 people
- Sponsor
- Medicure
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.
Coronary Artery Disease
SHIELD II Clinical Investigation
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with…
- Trial name
- SHIELD II (NCT02468778)
- Testing
- HeartMate PHP, Any Abiomed Impella® device approved for use in high-risk PCI
- Where
- 58 sites in United States
- Volunteers
- 54 people
- Sponsor
- Abbott Medical Devices