Clinical trials: High-risk Percutaneous Coronary Intervention
- Condition High-risk Percutaneous Coronary Intervention
- Funder type Industry (pharma, biotech, devices)
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
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
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
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 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
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
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
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
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
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.
Coronary Artery Disease, Percutaneous Coronary Intervention
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- DAPTLong (NCT06075433)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
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.
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
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.
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
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 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
- 26 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
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
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
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