Clinical trials: Coronary Bypass
Coronary Artery Disease
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing…
- Trial name
- VCAB-1 (NCT06434935)
- Testing
- CABA
- Where
- Paraguay
- Volunteers
- 5 people
- Sponsor
- Vascudyne, Inc.
Cardiac Surgery, Cardiopulmonary Bypass
Safety and Efficacy of Preoperative Antithrombin Supplementation in Patients Undergoing High-Risk Cardiopulmonary Bypass
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The purpose of this study is to determine the safety and effectiveness of human-derived antithrombin III (AT-III [Human]) supplementation…
- Trial name
- NCT02037555
- Testing
- AT-III (Human)
- Where
- 41 sites in United States
- Volunteers
- 425 people
- Sponsor
- Grifols Therapeutics LLC
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
Bleeding, Bypass Complication
A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement
Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding.
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Trial name
- NCT05542277
- Testing
- ClearPlasma
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 130 people
- Sponsor
- PlasFree Ltd.
Coronary Disease
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.
- Trial name
- NCT00316212
- Testing
- INS50589 Intravenous Infusion
- Where
- 27 sites in United States
- Volunteers
- 160 people
- Sponsor
- Merck Sharp & Dohme LLC
Low Cardiac Output
The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach…
- Trial name
- NCT00529711
- Testing
- Hypertonic lactate, Ringer's lactate
- Where
- Indonesia
- Volunteers
- 66 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Cardiac Surgery
Efficacy and Safety of Sodium Heparin (Eurofarma)
The objective of this study is to verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require…
- Trial name
- NCT00894829
- Testing
- heparin sodium - Eurofarma, heparin sodium - APP
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Azidus Brasil
Coronary Artery Disease, Myocardial Ischemia
The eSVS® Mesh Randomized Post-Market Study
The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases
- Trial name
- NCT01462721
- Testing
- eSVS® Mesh
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Kips Bay Medical, Inc.
Myocardial Ischemia, Coronary Arteriosclerosis
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery
The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo…
- Conditions
- Myocardial Ischemia, Coronary Arteriosclerosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT00082121
- Testing
- TP10
- Where
- 18 sites in United States
- Volunteers
- 300 people
- Sponsor
- Avant Immunotherapeutics
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
CPB, Oral Anticoagulant Therapy
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).
- Trial name
- NCT00151853
- Testing
- PPSB-SD
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Prothya Biosolutions
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
Symptomatic Ischemic Saphenous Vein Graft Disease
Symbiot III: A Prospective Randomized Trial Evaluating the Symbiot Covered Stent System in Saphenous Vein Grafts
The objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein bypass graft disease.
- Trial name
- NCT00283413
- Testing
- Covered Stent System, Bare metal stent
- Where
- 49 sites in United States, Canada
- Volunteers
- 514 people
- Sponsor
- Boston Scientific Corporation
Acute Kidney Injury (AKI)
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
- Trial name
- NCT04829916
- Testing
- RMC-035
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Guard Therapeutics AB
Post-discharge Outcomes
Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery
This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.
- Trial name
- NCT07009340
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Renibus Therapeutics, Inc.
Major Coronary Event, Cerebrovascular Accident
CARDS Is Designed To Show If Lowering Cholesterol With Atorvastatin In Type 2 Diabetics Without CV Disease Reduces The Risk Of CV Events
A study to assess the efficacy of once daily atorvastatin 10 mg versus placebo on cardiovascular endpoints in patients with non-insulin-dependent diabetes mellitus (NIDDM) who have a history of either hypertension, retinopathy…
- Conditions
- Major Coronary Event, Cerebrovascular Accident, Coronary Artery Bypass Graft, Angina, Unstable
- Trial name
- CARDS (NCT00327418)
- Testing
- Atorvastatin
- Where
- 135 sites in United Kingdom
- Volunteers
- 2,800 people
- Sponsor
- Pfizer
Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)
The eMESH 1 Feasibility Study
Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc.
- Trial name
- eMESH 1 (NCT01676376)
- Testing
- eSVS Mesh treated saphenous vein graft, Control saphenous vein graft
- Where
- 15 sites in United States, Czechia and 5 more
- Volunteers
- 120 people
- Sponsor
- Kips Bay Medical, Inc.
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Ischemic Heart Disease
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
ADR-002K is administered to heart failure patients with ischemic heart disease who undergo coronary artery bypass surgery (CABG) to investigate its efficacy and safety.
- Trial name
- NCT07192211
- Testing
- Mesenchymal stem cell
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.
Patient With Clinically Indicated Invasive Monitoring
ClearSight System CHN Study
The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary…
- Trial name
- NCT03807622
- Testing
- EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
- Where
- 3 sites in China
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences