Clinical trials: Stenoses
Coronary Artery Disease, Myocardial Infarction
Clinical Evaluation of Radiation Reduction for Optimized Safety
The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce…
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Coronary Disease, Coronary Stenosis
- Trial name
- CERROS (NCT06348875)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Angiowave Imaging
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
- Trial name
- NCT04068402
- Testing
- Vivio System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
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
Small Vessel Lesion
Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)
Study Purpose The safety and efficacy of paclitaxel controlled release balloon catheter VasoguardTM in treatment of small vessel lesion.
- Trial name
- NCT02891005
- Testing
- paclitaxel controlled release balloon catheter (VasoguardTM), common balloon catheter (Maverick2)
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Shandong Branden Med.Device Co.,Ltd
Aortic Stenosis, Aortic Insufficiency
First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair
This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
- Trial name
- NCT04178213
- Testing
- Implantation of ADAPT 3D ALR
- Where
- Belgium
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Symptomatic Aortic Stenosis
Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System
This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up…
- Trial name
- VIVA (NCT04861805)
- Testing
- Vienna Aortic Valve SE System
- Where
- 31 sites in Argentina, Brazil and 6 more
- Volunteers
- 267 people
- Sponsor
- P+F Products + Features GmbH
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery…
- Trial name
- NCT01113983
- Testing
- Transcatheter aortic valve implantation
- Where
- 3 sites in Japan
- Volunteers
- 64 people
- Sponsor
- Edwards Lifesciences
Arteriovenous Fistula
FLEX®-DCB Dialysis ACCESS Stenosis Study
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.
- Trial name
- AVAFLEX (NCT03566927)
- Testing
- FLEX Scoring Catheter with Lutonix DCB
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- VentureMed Group Inc.
Atherosclerotic Heart Disease
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
- Trial name
- NCT01816854
- Testing
- Stenting
- Where
- Belgium
- Volunteers
- 117 people
- Sponsor
- be Medical
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Coronary Artery Stenosis
Angiography Study of BioNIR Drug Eluting Stent System (NIREUS)
The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison to the Resolute zotarolimus-eluting stent (hereafter…
- Trial name
- NIREUS (NCT01995500)
- Testing
- BioNIR, Resolute
- Where
- Israel
- Volunteers
- 300 people
- Sponsor
- Medinol Ltd.
Peripheral Arterial Disease, Stenosis
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.
- Conditions
- Peripheral Arterial Disease, Stenosis, Intermittent Claudication
- Trial name
- NCT00424866
- Testing
- FGF-1
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Venturis Therapeutics, Inc.
Coronary Stenosis, Coronary Disease
BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial
Device: EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length) Objectives: To further assess the safety and…
- Conditions
- Coronary Stenosis, Coronary Disease, Myocardial Ischemia, Cardiovascular Diseases
- Trial name
- NCT04761939
- Testing
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Where
- 9 sites in Israel
- Volunteers
- 81 people
- Sponsor
- Medinol Ltd.
Superficial Esophageal Cancer
A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group
The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial…
- Trial name
- NCT04689594
- Testing
- CLS2702C/CLS2702D
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- CellSeed Inc.