Clinical trials: Distension
Heart Failure, Myocardial Infarction
A Multinational Trial to Evaluate the Longterm Safety of the Parachute Implant System
The primary objective is to assess the longterm 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
- PARACHUTEIII (NCT01297296)
- Where
- 13 sites in Belgium, Germany and 4 more
- Volunteers
- 54 people
- Sponsor
- CardioKinetix, Inc
Peripheral Arterial Disease
Effectiveness and Safety Study of Peripheral Balloon Dilatation Catheter in Percutaneous Transluminal Angioplasty(PTA) Procedure
The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.
- Trial name
- NCT01849601
- Testing
- percutaneous transluminal angioplasty balloon catheter
- Where
- China
- Volunteers
- 167 people
- Sponsor
- Acotec Scientific Co., Ltd
Coronary Artery Disease
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.
- Trial name
- NCT01635881
- Testing
- Emerge™ 1.20 mm PTCA Dilatation Catheter
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Physiologic Venous Dilation, Air Travel
Prospective Repeated-Measures Study of Popliteal Vein Diameter During the First 48 Hours After Commercial Air Travel to Bogota for a Plastic Surgery Intervention
This prospective repeated-measures study will evaluate how long popliteal vein dilation persists after international commercial air travel to Bogota.
- Trial name
- NCT07808411
- Testing
- Commercial Air Travel Exposure, Standardized Bilateral Popliteal Vein Duplex Ultrasound
- Where
- Colombia
- Volunteers
- 100 people
- Sponsor
- Research Inc
Aortic Valve Stenosis
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
The primary objective of this study is to collect data to confirm the performance and safety of the True™ Flow Valvuloplasty Perfusion Catheter during dilatation of the aortic valve in the preparation for Transcatheter Aortic…
- Trial name
- True™Flow (NCT02847546)
- Testing
- True™ Flow Valvuloplasty Perfusion Catheter
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- C. R. Bard
AAA - Abdominal Aortic Aneurysm, Aorta Aneurysm
Nectero EAST System Retreatment Study
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
- Conditions
- AAA - Abdominal Aortic Aneurysm, Aorta Aneurysm, Dilation Aorta
- Trial name
- NCT07505082
- Testing
- Nectero EAST System
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 10 people
- Sponsor
- Nectero Medical, Inc.
Sinusitis
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study
The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.
- Trial name
- NCT01612780
- Testing
- XprESS Multi-Sinus Dilation Tool
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Entellus Medical, Inc.
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
Peripheral Arterial Disease, Peripheral Arterial Disease(PAD)
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
- Trial name
- NCT06758921
- Testing
- Oscar Peripheral Multifunctional Catheter
- Where
- 16 sites in Austria, Belgium and 6 more
- Volunteers
- 200 people
- Sponsor
- Biotronik AG
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
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.
Eustachian Tube Dysfunction
XprESS ET Registry
A prospective, multicenter, registry of patients undergoing balloon dilation of the Eustachian tubes (ET).
- Trial name
- NCT04136977
- Testing
- Eustachian tube dilation
- Where
- 11 sites in United States
- Volunteers
- 169 people
- Sponsor
- Entellus Medical, Inc.
Coronary Arteriosclerosis
Scoreflex TRIO - Scoring PTCA Catheter
To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary…
- Trial name
- NCT05929313
- Testing
- OrbusNeich Scoreflex TRIO, OrbusNeich Scoreflex NC
- Where
- 4 sites in China
- Volunteers
- 210 people
- Sponsor
- OrbusNeich
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
Corneal Ectasia
Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery
The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic…
- Trial name
- CXL (NCT03319082)
- Testing
- Corneal Collagen Cross-linking
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Glaukos Corporation
Coronary Stenosis, Coronary Artery Stenosis
Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease
The objective of this study is to evaluate safety and effectiveness of the SINOMED CBC coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- NCT05509296
- Testing
- SINOMED CBC, NSE Coronary Dilatation Catheter
- Where
- 8 sites in China
- Volunteers
- 136 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Peripheral Artery Disease
BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
- Trial name
- BIONETIC-I (NCT04830228)
- Testing
- Ballon expandable stent and PTA
- Where
- 15 sites in Austria, Belgium and 4 more
- Volunteers
- 160 people
- Sponsor
- Biotronik AG
Keratoconus, Corneal Diseases
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.
- Conditions
- Keratoconus, Corneal Diseases, Eye Diseases, Photosensitizing Agents
- Trial name
- NCT03029104
- Testing
- CXLO Corneal Strengthening Solution and UVA Illumination Device
- Where
- 9 sites in United States
- Volunteers
- 2,228 people
- Sponsor
- Cxlusa
Intrauterine Adhesion
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in…
- Trial name
- NCT03353909
- Testing
- new crosslinked hyaluronan gel
- Volunteers
- 300 people
- Sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
Arteriovenous Fistula Stenosis
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous…
- Trial name
- SCDB (NCT06422845)
- Testing
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Where
- 33 sites in China
- Volunteers
- 328 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.