Clinical trials: High Risk Percutaneous Coronary Interventions
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 Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the…
- Trial name
- NCT07025148
- Testing
- Prasugrel, Clopidogrel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida
Coronary Artery Disease
Myocardial Injury After Elective Coronary Stenting
This pilot study aims to identify patients at moderate to high risk for peri-procedural (type 4) myocardial infarction or injury after after undergoing an elective coronary intervention (PCI) as measured by high sensitivity…
- Trial name
- NCT01986621
- Where
- Germany
- Volunteers
- 530 people
- Sponsor
- University Hospital Heidelberg
Coronary Artery Disease, Ischemic Heart Disease
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding.
- Trial name
- ACO_FLEX (NCT06863155)
- Testing
- Supraflex Cruz Sirolimus-eluting Stent
- Where
- 13 sites in Spain
- Volunteers
- 500 people
- Sponsor
- Fundación EPIC
ST Elevation Myocardial Infarction
Effect of Upstream Treatment With High Intensity Statin on the Outcomes of STMI Patients Treated With PPCI
Effect of upstream treatment with high intensity statin on the outcome of ST segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention
- Trial name
- NCT04754789
- Testing
- Atorvastatin, Aspirin
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Assiut University
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
Bleeding
Novel Approaches in Preventing and Limiting Events III Trial (NAPLES III): Bivalirudin in High-risk Bleeding Patients
Bleeding occurring during percutaneous coronary interventions (PCI has now emerged as one of the most common complication of PCI and adversely affect in-hospital, short- and long-term outcome.As bivalirudin proved its…
- Trial name
- NAPLESIII (NCT01465503)
- Testing
- Bivalirudin, Unfractionated Heparin
- Where
- 2 sites in Italy
- Volunteers
- 837 people
- Sponsor
- Clinica Mediterranea
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
Coronary Artery Disease
Multidisciplinary Program Based in High Intensity Interval Training and Dietary Education for Coronary Artery Disease
A multidisciplinary program based on physiotherapy and diet education will be carried out for 3 months in patients with coronary artery disease with percutaneous coronary intervention.
- Trial name
- NCT03796234
- Testing
- Dietary and physiotherapy, Physiotherapy
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- University of Valencia
Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR)
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy…
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07374718
- Testing
- IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy, Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
- Where
- China
- Volunteers
- 468 people
- Sponsor
- Shenyang Northern Hospital
PRU(Platelet Reactivity Unit), APT(Antiplatelet Therapy)
Platelet Reactivity (High On-Treatment Platelet Reactivity) as Guidance for APT (Antiplatelet Therapy) Adjustment After PCI (Percutaneous Coronary Intervention)
Since thrombus formation is a very complex procedure in vivo, platelet function testing methods in vitro might only reflect the degree of inhibition of platelet from a certain level, which do't reflect the functional status of…
- Conditions
- PRU(Platelet Reactivity Unit), APT(Antiplatelet Therapy), HOTPR(High on Treat Platelet Reactivity)
- Trial name
- NCT02101411
- Testing
- PRU(Platelet reactivity unit)
- Where
- Taiwan
- Volunteers
- 334 people
- Sponsor
- Taipei City Hospital
Platelet Reactivity
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg 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
- NCT01463150
- Testing
- Clopidogrel, Prasugrel
- Where
- Greece
- Volunteers
- 27 people
- Sponsor
- University of Patras
Coronary Artery Disease
Glasgow MRI and Rotablation Study
Percutaneous coronary intervention (PCI) with adjunctive high speed rotational atherectomy (HSRA) is commonly used to treat complex and calcified coronary artery stenoses.
- Trial name
- GlaMoRouS (NCT02857790)
- Volunteers
- 58 people
- Sponsor
- NHS National Waiting Times Centre Board
Coronary Artery Disease, High Risk PCI
CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
This is a prospective, multicenter, observational registry designed to evaluate clinical outcomes in patients undergoing complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) in China.
- Conditions
- Coronary Artery Disease, High Risk PCI, Percutaneous Coronary Intervention (PCI)
- Trial name
- CHIP-CC (NCT07557238)
- Testing
- Percutaneous Coronary Intervention, Mechanical Circulatory Support
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Guofeng Gao
Coronary Artery Disease
Safety and Efficacy of "Standardized" CHIP
In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI).
- Trial name
- NCT03212378
- Testing
- percutaneous coronary interventions
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- University Hospital, Essen
Coronary Artery Disease
Pressure-Volume Loop During High-Risk PCI
This study will examine the physiologic effects on loading conditions and contractility of the left ventricle during high-risk primary coronary intervention (HRPCI) in the Cardiac Cath Lab.
- Trial name
- NCT04681313
- Testing
- High-risk percutaneous coronary intervention
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Henry Ford Health System