Clinical trials: Distension
Healthy
Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. Finding safe and effective product able to improve endothelial function is of public health interest.
- Trial name
- NCT04697589
- Testing
- Memophenol 300 mg, Memophenol 600 mg
- Where
- France
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Activ'inside
Eustachian Tube Dysfunction
XprESS Eustachian Tube Dilation Study
Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.
- Trial name
- NCT02391584
- Testing
- XprESS, Control
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Entellus Medical, Inc.
Heart Failure
Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients
The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease.
- Trial name
- PARACHUTE (NCT00573560)
- Testing
- VPD Implant System
- Where
- 7 sites in United States, Serbia
- Volunteers
- 20 people
- Sponsor
- CardioKinetix, Inc
Healthy
Acute Strawberry Intake on Endothelial Function
The primary objectives of the study are (1) to evaluate the effects of acute dietary strawberry intake on measures of vascular function in healthy adults following a meal challenge, (2) to evaluate the effects of acute dietary…
- Trial name
- SFMD (NCT03596008)
- Testing
- Active drink
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Chronic Sinusitis
Balloon Sinus Dilation In Office or OR
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices.
- Trial name
- ORIOS (NCT00939393)
- Testing
- FESS instruments with or without balloon treatment, Balloon Sinuplasty
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Integra LifeSciences Corporation
Cardiovascular Disease, Cigarette Smoking
Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers
This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to compare selected CVD biomarker data between subjects who were long-term consumers of cigarettes or moist snuff and non-consumers of…
- Trial name
- NCT01692353
- Testing
- Subject's usual brand (UB) tobacco product
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- R.J. Reynolds Tobacco Company
Sinusitis
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS).
- Trial name
- ORIOS 2 (NCT01107379)
- Testing
- Relieva Balloon Sinuplasty System
- Where
- 3 sites in United States
- Volunteers
- 203 people
- Sponsor
- Integra LifeSciences Corporation
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.
Heart Failure, Myocardial Infarction
A Multinational Trial To Evaluate The Parachute Implant System
The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.
- Trial name
- PARACHUTE (NCT01286116)
- Testing
- Parachute Implant
- Where
- 13 sites in France, Germany and 6 more
- Volunteers
- 59 people
- Sponsor
- CardioKinetix, Inc
Percutaneous Coronary Intervention
The Safety and Efficacy of DIOR Balloon in Coronary Bifurcation Lesions
To evaluate the safety and effectiveness of paclitaxel-eluting coronary artery balloon dilation catheter (DIOR) in revascularization of coronary bifurcation lesions compared with paclitaxel-eluting balloon (Bingo), and to provide…
- Trial name
- BEYOND-II (NCT03820622)
- Testing
- Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR), Paclitaxel-Eluting Balloon (Bingo)
- Where
- 13 sites in China
- Volunteers
- 220 people
- Sponsor
- CCRF Inc., Beijing, China
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
Peripheral Arterial Disease, Iliac Artery Stenosis
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
- Conditions
- Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis
- Trial name
- NCT03844724
- Testing
- ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter, Peripheral Balloon Dilatation Catheter
- Volunteers
- 204 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Menopause, Hypertension
Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women
ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an effective and well-tolerated ACE-I for the treatment of patients with hypertension and congestive heart failure.
- Trial name
- NCT00147524
- Testing
- quinapril, Laser Doppler imaging
- Where
- 5 sites in Hungary
- Volunteers
- 70 people
- Sponsor
- Pfizer
Coronary Arterial Disease (CAD)
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for De Novo Coronary Bifurcation Lesions
Evaluating the Safety and Efficacy of Sirolimus-coated Coronary Balloon Dilatation Catheter vs Paclitaxel-coated balloon catheter for the Treatment of De Novo Coronary Bifurcation Lesions
- Trial name
- NCT06822712
- Testing
- Sirolimus-coated Balloon Dilatation Catheter, Paclitaxel-coated Balloon Dilatation Catheter
- Where
- China
- Volunteers
- 250 people
- Sponsor
- BrosMed Medical Co., Ltd
Sinusitis
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
- Trial name
- MERLOT (NCT01685229)
- Testing
- Balloon sinus dilation, Medical Management
- Where
- 20 sites in United States
- Volunteers
- 198 people
- Sponsor
- Integra LifeSciences Corporation
Peripheral Arterial Disease, Femoropopliteal Stenosis
PMCF Study for Peripheral Arteries Above the Knee (ATK)
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the…
- Conditions
- Peripheral Arterial Disease, Femoropopliteal Stenosis, Angiopathy, Peripheral
- Trial name
- NCT05312580
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 387 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Sprinter Legend Balloon Catheter
Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.
- Trial name
- NCT00961311
- Testing
- Percutaneous Coronary Intervention, Sprinter Legend 1.25mm Balloon Catheter
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Medtronic Vascular
Peripheral Artery Disease
PMCF Study for Peripheral Arteries Below the Knee (BTK)
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC)…
- Trial name
- NCT05444660
- Where
- 5 sites in Austria, Germany
- Volunteers
- 102 people
- Sponsor
- Cordis US Corp.
Carotid Artery Stenoses
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
- Trial name
- NCT02501148
- Testing
- carotid artery stenting
- Where
- 5 sites in Germany
- Volunteers
- 106 people
- Sponsor
- Contego Medical, Inc.
Endothelial Function, Oxidative Stress
Black Forest Cocoa Flavanol Supplementation and Health Trial
This randomized, double-blind, controlled clinical trial will evaluate the effects of daily cocoa flavanol supplementation on vascular and inflammatory biomarkers in healthy adult men aged 30 to 75 years.
- Conditions
- Endothelial Function, Oxidative Stress, Inflamation, Vascular Health
- Trial name
- NCT07747714
- Testing
- Cocoa Flavanol Supplement, Low-Flavanol Control Powder
- Where
- 2 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- The Black Forest LLC