Clinical trials: Small Vessel Ischemic Disease
Coronary Artery Diseases
BIOFLOW-III UK Satellite Registry Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
- Trial name
- NCT02257710
- Testing
- Orsiro
- Where
- 4 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- Biotronik UK Ltd.
Anterior Wall Acute Myocardial Infarction
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)
The primary objective of the study is to collect confirmatory data supporting the safety and effectiveness of SSO2 Therapy in treatment of anterior acute myocardial infarction (AMI) patients who have undergone successful…
- Trial name
- IC-HOT (NCT02603835)
- Testing
- SSO2 Therapy
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- TherOx
Coronary Artery Disease, Drug Eluting Balloon
Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial
The main objective of the SPARX trial is to compare paclitaxel-coated balloons to with contemporary DES in complex and small coronary artery lesions in patients with NSTEACS or CCS; the co-primary objective is to compare two…
- Conditions
- Coronary Artery Disease, Drug Eluting Balloon, Drug Eluting Stent
- Trial name
- SPARX RCT (NCT07397845)
- Testing
- Protégé and Protégé NC, Agent, Drug Eluting Stent
- Where
- Switzerland
- Volunteers
- 1,380 people
- Sponsor
- Translumina GmbH
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Coronary Heart Disease
The First-In-Man Pilot Study of Firehawk
This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body.
- Trial name
- NCT02688829
- Testing
- Rapamycin target-eluting Coronary Stent System
- Volunteers
- 21 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
Coronary Artery Disease, Native Coronary Artery Stenosis
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
- Trial name
- MAGICAL SV (NCT06271590)
- Testing
- Sirolimus Drug Coated Balloon, Drug eluting stents (DES)
- Where
- 24 sites in United States
- Volunteers
- 1,605 people
- Sponsor
- Concept Medical Inc.
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
Coronary Disease
ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.
- Trial name
- NCT04626687
- Testing
- test DCB, RESTORE DCB
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Acotec Scientific Co., Ltd
Coronary Artery Disease (CAD), Stenosis Coronary
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease
- Trial name
- PCI EVOlution (NCT07491107)
- Testing
- Inspiron EVO Drug-Eluting Stent
- Where
- Brazil
- Volunteers
- 2,000 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Romania Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01593059
- Where
- 4 sites in Romania
- Volunteers
- 13 people
- Sponsor
- Biotronik Vertriebs-GmbH
Coronary Artery Disease
A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease
- Trial name
- NCT04953117
- Testing
- DCB of Lepu Medical(dimeter≥2.00 mm), Restore DEB, DCB of Lepu Medical(dimeter<2.00 mm)
- Where
- 14 sites in China
- Volunteers
- 286 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Coronary Stenosis
Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease
The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel eluting balloon in the treatment of Chinese patients with coronary heart disease and small vessel lesions in comparison with RESOLUTE…
- Trial name
- NCT02946307
- Testing
- Restore DEB（dimeter>2.00 mm）, Resolute DES, Restore DEB（dimeter:2.00 mm）
- Where
- 12 sites in China
- Volunteers
- 240 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Coronary Artery Disease(CAD)
Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion
The GENOSS PCB-De Novo study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with De novo small coronary artery…
- Trial name
- PCB-De Novo (NCT07158307)
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Disease
The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions.
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as…
- Trial name
- SVELTE (NCT00235066)
- Testing
- PCI
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III All-comers Orsiro Safety and Performance Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- BIOFLOW-III (NCT01553526)
- Where
- 43 sites in Austria, Chile and 11 more
- Volunteers
- 1,356 people
- Sponsor
- Biotronik AG
In-stent Restenosis, Ischemic Heart Disease
The PREVAIL Study
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with…
- Conditions
- In-stent Restenosis, Ischemic Heart Disease, Coronary Artery Disease
- Trial name
- PREVAIL (NCT03260517)
- Testing
- Medtronic Coronary Drug-Coated Balloon Catheter
- Where
- 10 sites in Belgium, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Vascular
Cadasil
Efficacy and Safety of Tocotrienols in CADASIL
CADASIL is a paradigmatic cerebral small vessel disease responsible for white-matter lesions, accumulation of lacunes, microbleeds and cerebral atrophy.
- Trial name
- NCT04658823
- Testing
- HOV-12020 (Palm tocotrienols complex)
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Hovid Berhad
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Israel Satellite Registry
BIOTRONIK - SaFety and Performance Registry for a diabetic patient population with the .bimus Eluting Orsiro Stent System Within daily clinical practice - III
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01895712
- Where
- 6 sites in Israel
- Volunteers
- 120 people
- Sponsor
- BIOTRONIK Israel
Neurologic Disorder, Paralysis
SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex.
- Conditions
- Neurologic Disorder, Paralysis, Paralysis; Stroke, Amyotrophic Lateral Sclerosis
- Trial name
- NCT05041114
- Testing
- Motor Neuroprosthesis
- Where
- 3 sites in Australia
- Sponsor
- Synchron Medical, Inc.