Clinical trials: Ectasia
Arteriovenous Fistula
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula
This prospective, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Tri-wire Peripheral Balloon Dilatation Catheter compared to a standard PTA Catheter in treating subjects…
- Trial name
- NCT04393688
- Testing
- Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter
- Where
- 7 sites in China
- Volunteers
- 168 people
- Sponsor
- BrosMed Medical Co., Ltd
Keratoconus
CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional…
- Trial name
- NCT01956474
- Testing
- Theralight crosslinking and Riboflavin
- Where
- 6 sites in United States
- Volunteers
- 1,324 people
- Sponsor
- Cxlusa
Abdominal Aortic Aneurysm, AAA
First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)
This is a first in human study to evaluate the safety and clinical utility of an investigational medical device called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
- Conditions
- Abdominal Aortic Aneurysm, AAA, Dilation Aorta
- Trial name
- AAA (NCT05133492)
- Testing
- Endovascular Aneurysm Stabilization Treatment (EAST)
- Where
- 5 sites in Australia, China and 3 more
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nectero Medical, Inc.
Coronary Artery Disease, Coronary Disease
Sapphire II PRO US Clinical Study
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with…
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases
- Trial name
- NCT03052530
- Testing
- Sapphire II PRO
- Where
- 4 sites in United States
- Volunteers
- 61 people
- Sponsor
- OrbusNeich
Irritable Bowel Syndrome (IBS)
Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation
- Trial name
- NCT00584298
- Testing
- SMS995
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- Novartis
Hyperlipidemia
Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.
- Trial name
- Oasis Flow (NCT02824432)
- Testing
- TAK-085
- Where
- 4 sites in Japan
- Volunteers
- 37 people
- Sponsor
- Takeda
Cardiovascular Diseases
Vascular Reactivity Assessment by the AngioDefender Device -- A Precision Study
The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.
- Trial name
- NCT02641197
- Testing
- AngioDefender
- Where
- 2 sites in Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Everist Genomics, Inc
Mydriasis
Evaluation of Pupil Dilation Speed With the MAP Dispenser
1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation
- Trial name
- SPEED (NCT04907474)
- Testing
- tropicamide-phenylephrine fixed combination ophthalmic solution
- Where
- Mexico
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Eyenovia Inc.
Heart Failure
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the…
- Trial name
- TurkuPET (NCT03300427)
- Testing
- sacubitril/valsatran, valsartan
- Where
- Finland
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Tricuspid Regurgitation Functional
Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System
An early feasibility study to evaluate the safety and performance of 1) the transcatheter delivery and implantation of the Cardiac Implants (CI) annuloplasty ring and 2) the adjustment of the ring approximately 90 days following…
- Trial name
- NCT04890821
- Testing
- CI Percutaneous Ring Annuloplasty System
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cardiac Implants LLC
In-Stent Restenosis or De Novo Coronary Artery Lesions
Coronary Artery Drug-Coated Balloon Dilatation Catheter Clinical Trial Protocol
This clinical trial adopts a retrospective, multicenter design with data registered and collected via an Electronic Data Capture (EDC) system.
- Trial name
- NCT07415902
- Testing
- Coronary Artery Drug-Coated Balloon Dilatation Catheter
- Where
- China
- Volunteers
- 252 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
XprESS Maxillary Balloon Dilation Study
A prospective, single-arm, post approval pilot study.
- Trial name
- NCT01525862
- Testing
- Balloon sinus dilation
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Entellus Medical, Inc.
Peripheral Arterial Disease
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
- Trial name
- NCT06029569
- Testing
- Rapamycin drug balloon angioplasty, Paclitaxel drug balloon angioplasty
- Volunteers
- 256 people
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
Sinusitis
Balloon REmodeling Antrostomy THErapy Study
This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis.
- Trial name
- BREATHE I (NCT00645762)
- Testing
- RS-Series Rhinosinusitis Treatment System, FinESS Balloon
- Where
- 13 sites in United States
- Volunteers
- 71 people
- Sponsor
- Entellus Medical, Inc.
Dysfunction of Eustachian Tube
AERA Pediatrics Registry
Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
- Trial name
- NCT07071298
- Where
- 9 sites in United States
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
Dilated Cardiomyopathy (DCM)
A Phase 1 AAV Gene Therapy Trial Evaluating Safety and Preliminary Efficacy of RP-A701 in Subjects With BAG3 Dilated Cardiomyopathy
This is a Phase 1, open-label, dose-escalation trial to characterize the safety, tolerability, and preliminary efficacy of RP-A701 following a single IV administration in high-risk adult patients with BAG3-DCM.
- Trial name
- NCT07137338
- Testing
- RP-A701 is a recombinant viral vector composed of an AAV serotype rh.74 (AAVrh.74) capsid encapsulating the transgene, BCL2-associated Athanogene 3 (BAG3)
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Carotid Artery Stenosis, Carotid Artery Diseases
Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System
A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following…
- Conditions
- Carotid Artery Stenosis, Carotid Artery Diseases, Carotid Stenosis
- Trial name
- PERFORMANCE II (NCT04201132)
- Testing
- Carotid artery stenting with Neuroguard IEP System
- Where
- 38 sites in United States, Bulgaria and 4 more
- Volunteers
- 305 people
- Sponsor
- Contego Medical, Inc.
Carotid Stenosis, Carotid Artery Diseases
Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at…
- Trial name
- NCT05845710
- Testing
- Neuroguard IEP Direct System
- Where
- 32 sites in United States, France
- Volunteers
- 178 people
- Sponsor
- Contego Medical, Inc.
Peripheral Artery Disease
Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions…
- Trial name
- NCT02278991
- Testing
- Lutonix Drug Coated Balloon
- Where
- 12 sites in Germany, Greece and 1 more
- Volunteers
- 149 people
- Sponsor
- C. R. Bard