Clinical trials: High Risk Percutaneous Coronary Interventions
- Condition High Risk Percutaneous Coronary Interventions
- Funder type Industry (pharma, biotech, devices)
High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
- Trial name
- VITALYST EFS (NCT06132568)
- Testing
- VITALYST System
- Where
- 5 sites in United States, Sweden
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
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
Coronary Artery Disease
PMCF Study for Cardiology Access Procedures
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the…
- Trial name
- NCT05543096
- Testing
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Where
- 8 sites in Austria, Belgium
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
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.
Acute Coronary Disease, Angina Unstable
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a…
- Trial name
- CURRENT/OASIS7 (NCT00335452)
- Testing
- Clopidogrel, acetylsalicyclic acid (ASA)
- Where
- 38 sites in United States, Argentina and 36 more
- Volunteers
- 25,086 people
- Sponsor
- Sanofi
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
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.
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.
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
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.
High-risk PCI
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd.
- Trial name
- NCT07622446
- Testing
- OmniHeart 4.0 Percutaneous Ventricular Assist Device, ECMO
- Where
- 2 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Dynaheart Medtech Co., Ltd.
Coronary Artery Disease, High-risk Percutaneous Coronary Intervention
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI
The objective of this study is to assess the feasibility and safety 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
- Trial name
- NCT06087575
- Testing
- Supira System
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Supira Medical
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
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
Bioflow-DAPT Study
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx.
- Trial name
- NCT04137510
- Testing
- Percutaneous coronary intervention
- Where
- 53 sites in Australia, Austria and 16 more
- Volunteers
- 1,948 people
- Sponsor
- Biotronik AG
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
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.
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
Complex Coronary Lesions
Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or…
- Trial name
- IVUS-CHIP (NCT04854070)
- Testing
- IVUS, Angio
- Where
- 37 sites in Belgium, France and 5 more
- Volunteers
- 2,020 people
- Sponsor
- ECRI bv
Ventricular Assist Device
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
- Trial name
- SUPPORT CE (NCT06565039)
- Testing
- Supira System
- Sponsor
- Supira Medical