Clinical trials: High-Risk Percutaneous Coronary Intervention
- Condition High-Risk Percutaneous Coronary Intervention
- Funder type Industry (pharma, biotech, devices)
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
High-Risk PCI
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump…
- Trial name
- NCT07010965
- Testing
- NyokAssist™, IABP Intra-aortic balloon pump
- Where
- 12 sites in China
- Volunteers
- 236 people
- Sponsor
- magAssist, Inc.
Coronary Disease
RIAPRE - Non-interventional Registry of Anticoagulation Treatment (BI-006-IT)
RIAPRE is a non-interventional registry to be settled in Italy with the purpose of collecting data on 600 cases of high risk elective percutaneous coronary intervention (PCI) patients treated with an anticoagulation regime…
- Trial name
- NCT00317343
- Testing
- Bivalirudin (thrombin specific anticoagulant)
- Sponsor
- Nycomed
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 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
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
HeartMate PHP™ CE Mark Clinical Investigation Plan
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable…
- Trial name
- HM PHP CE Mark (NCT02156609)
- Testing
- Percutaneous ventricular support with the HeartMate PHP
- Where
- 7 sites in Colombia, Netherlands and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)
- Trial name
- Vortex-FIH (NCT04674111)
- Testing
- Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
- Where
- 2 sites in Australia, Sweden
- Volunteers
- 5 people
- Sponsor
- Boston Scientific Corporation
Bleeding Disorder, Ischemic Stroke
XIENCE 28 USA Study
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR)…
- Conditions
- Bleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases
- Trial name
- NCT03815175
- Testing
- XIENCE, DAPT (aspirin and/or P2Y12 receptor inhibitor)
- Where
- 111 sites in United States, Austria and 13 more
- Volunteers
- 1,605 people
- Sponsor
- Abbott Medical Devices
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
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.
Coronary Disease, Drug Eluting Stent
Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal…
- Conditions
- Coronary Disease, Drug Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- NCT03287167
- Testing
- 1 month DAPT, 6 months DAPT
- Where
- China
- Volunteers
- 1,720 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease
EVOLVE Short DAPT Study
The EVOLVE Short DAPT Study is a prospective, multicenter, single-arm study designed to assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with a SYNERGY Stent System.
- Trial name
- NCT02605447
- Testing
- 3 months of dual antiplatelet therapy (DAPT), SYNERGY Stent System
- Where
- 110 sites in United States, Brazil and 5 more
- Volunteers
- 2,009 people
- Sponsor
- Boston Scientific Corporation
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
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.
Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI)
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients.
- Conditions
- Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI), Stable Angina (Associated With High Risk PCI)
- Trial name
- NCT01020383
- Testing
- ALX-0081, ReoPro®
- Where
- 39 sites in Austria, Belgium and 5 more
- Volunteers
- 364 people
- Sponsor
- Ablynx, a Sanofi company
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
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 Lesions
XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary…
- Trial name
- NCT03218787
- Testing
- XIENCE, DAPT
- Where
- 101 sites in United States
- Volunteers
- 2,047 people
- Sponsor
- Abbott Medical Devices
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