Clinical trials: Coronary Bypass
Coronary Artery Disease
Rise Semi Compliant Balloon Study in Patient With CAD
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for…
- Trial name
- NCT04796038
- Testing
- Balloon dilatation
- Where
- 3 sites in Switzerland
- Volunteers
- 67 people
- Sponsor
- Biosensors Europe SA
Heart Disease
Initial Experience With the AngioVac Venous Drainage Cannula
This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal…
- Trial name
- NCT02775565
- Testing
- AngioVac
- Where
- 5 sites in United States
- Volunteers
- 51 people
- Sponsor
- Angiodynamics, Inc.
Heart Diseases, Lung Diseases
TandemHeart Experiences and MEthods (THEME Registry)
This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use…
- Trial name
- THEME (NCT02326402)
- Testing
- TandemHeart or LifeSPARC System
- Where
- 16 sites in United States
- Volunteers
- 365 people
- Sponsor
- CardiacAssist, Inc.
Coronary Artery Disease
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either…
- Trial name
- SYNTAX (NCT00114972)
- Testing
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent, Coronary Artery Bypass Surgery
- Where
- 106 sites in United States, Austria and 16 more
- Volunteers
- 1,800 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Bypass Grafting (CABG), Chronic Heart Failure
A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure
B2278 is a human umbilical cord mesenchymal stem cell (HucMSCs) injection derived from the umbilical cord. It has the advantages of stronger immune regulation, stronger expansion capacity, lower immunogenicity, and greater…
- Conditions
- Coronary Artery Bypass Grafting (CABG), Chronic Heart Failure, Chronic Ischemic Cardiomyopathy
- Trial name
- NCT07265349
- Testing
- Mesenchymal stem cells(HucMSCs), CABG
- Where
- 4 sites in China
- Volunteers
- 51 people
- Sponsor
- Tasly Pharmaceutical Group Co., Ltd
Left Ventricular Dysfunction
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5)…
- Trial name
- IMPACT (NCT05529654)
- Testing
- Impella 5.5 with SmartAssist
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
Coronary Artery Bypass Surgery
Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery
This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during…
- Trial name
- NCT00858936
- Testing
- IK-1001, Normal Saline
- Where
- 8 sites in Australia, Canada
- Volunteers
- 6 people
- Sponsor
- Mallinckrodt
Ventricular Septal Defect, Atrioventricular Septal Defect
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects.
- Conditions
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- Trial name
- NCT05253209
- Testing
- L-citrulline, Plasmalyte A
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Atrial Fibrillation
A Randomized Study to Demonstrate the Safety and Feasibility of Plexisyl-AF in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
The primary goal of this study is to assess the safety of Plexisyl-AF administered by direct application to the cardiac fat pads in patients undergoing coronary artery bypass grafting.
- Trial name
- NCT00562432
- Testing
- Plexisyl-AF, No Treatment
- Where
- 3 sites in Germany
- Volunteers
- 32 people
- Sponsor
- LoneStar Heart, Inc.
Non-anaemic Patients Undergoing Cardiac Surgery
A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof
The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery
- Trial name
- CABG-01 (NCT01563367)
- Testing
- Iron isomaltoside 1000 (Monofer®), Natriumklorid 9 mg/ml, Fresenius Kabi
- Where
- Denmark
- Volunteers
- 74 people
- Sponsor
- Pharmacosmos A/S
Congestive Heart Failure
BMAC Enhanced Coronary Artery Bypass Grafting (CABG)
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.
- Trial name
- NCT01061580
- Testing
- Harvest SmartPReP2 BMAC System
- Where
- India
- Volunteers
- 20 people
- Sponsor
- Harvest Technologies
Low Cardiac Output
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass…
- Trial name
- NCT00529490
- Testing
- Hypertonic lactate, Ringer's lactate
- Where
- Indonesia
- Volunteers
- 230 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Hypotension, Cardiopulmonary Bypass
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.
- Trial name
- NCT00482287
- Testing
- MTR105
- Where
- United States
- Sponsor
- Meditor Pharmaceuticals Ltd.
Elective Cardiac Surgery
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
- Trial name
- REFRESH II-AKI (NCT03384875)
- Testing
- CytoSorb
- Where
- 20 sites in United States
- Volunteers
- 186 people
- Sponsor
- CytoSorbents, Inc
Coronary Heart Disease
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids.
- Trial name
- NCT01654653
- Testing
- Hypertonic sodium lactate, 6% Hydroxy Ethyl Starch
- Where
- Indonesia
- Volunteers
- 100 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Coronary Heart Disease, Multi Vessel Coronary Artery Disease
Optilene® Suture for Coronary Artery Bypass Graft Surgery
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
- Trial name
- OPTICABG (NCT02546557)
- Testing
- Coronary Artery Bypass Graft surgery
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 245 people
- Sponsor
- Aesculap AG
Off Pump Coronary Artery Bypass Surgery
Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops
The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops).
- Trial name
- LeGoo (NCT00985634)
- Testing
- LeGoo, Control
- Where
- Germany
- Volunteers
- 110 people
- Sponsor
- Pluromed, Inc.
Cardiopulmonary Bypass Surgery
HPI (Hypotension Prediction Index) Care Trial
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients…
- Trial name
- NCT05083403
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Edwards Lifesciences
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Coronary Artery Bypass Surgery
CD0104 VEST II Post Marketing Surveillance Study
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.
- Trial name
- VEST II (NCT02332330)
- Testing
- VEST
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Vascular Graft Solutions Ltd.