Clinical trials: Stenoses
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Stenoses, Carotid Artery
Selective Versus Routine Shunting in Carotid Endarterectomy Patients
The project involves prospectively randomizing patients to either routine carotid shunting or selective carotid shunting during Carotid endarterectomy (CEA) under general anesthesia (GA) to see the difference in post-op…
- Trial name
- NCT00967486
- Testing
- Carotid endarterectomy with routine shount, Carotid endarterectomy with selective shunt
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- CAMC Health System
Biliary Stricture
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture…
- Trial name
- NCT01543256
- Testing
- WallFlex™ Biliary RX Fully Covered Stent System RMV, Commercially available Plastic Stent Per Investigator preference
- Where
- 14 sites in Australia, Austria and 9 more
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Venous Thrombosis
The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity.
- Trial name
- NCT01406795
- Testing
- Gore Viabahn Heparin Coated Stent
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stanford University
Pulmonary Artery Stenosis
Cutting Balloon Study
The primary objective of this study is to evaluate the safety and efficacy of transcatheter Cutting Balloon therapy for branch pulmonary artery stenosis resistant to low pressure dilation.
- Trial name
- CB (NCT01205568)
- Testing
- Transcatheter Cutting Balloon therapy, High Pressure Balloon Angioplasty
- Where
- 6 sites in United States
- Volunteers
- 73 people
- Sponsor
- Boston Children's Hospital
Cardiovascular Diseases, Hypertension
Vascular Dysfunction in Hypertensive Postmenopausal Women
The purpose of this study is to investigate the role of ET-1 in mediating vasoconstrictor tone in hypertensive postmenopausal women (PMW) alone and in combination with a commonly prescribed Angiotensin II (ANG II) antagonist.
- Trial name
- NCT03371823
- Testing
- Normotensive, Hypertensives
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Femoral Artery Stenosis, Popliteal Artery Stenosis
IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- INPACT SFA II (NCT01566461)
- Testing
- Drug-Coated Balloon (DCB), PTA Balloon: Balloon Angioplasty
- Where
- 2 sites in United States
- Volunteers
- 331 people
- Sponsor
- Medtronic Endovascular
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Coronary Stenosis, Coronary Artery Stenosis
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- EXPANSE-PTCA (NCT04985773)
- Testing
- Lacrosse NSE ALPHA coronary dilatation catheter
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Infraredx
Coronary Artery Disease, Coronary Stenosis
Physiologic Assessment of Coronary Stenosis Following PCI
This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Angina, Unstable, Angina, Stable
- Trial name
- DEFINE PCI (NCT03084367)
- Testing
- iFR pullback
- Where
- 28 sites in United States, Netherlands and 1 more
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Stenosis
BIONICS Israel Trial
This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent - BioNIR - with a modified delivery system.
- Trial name
- NCT02834806
- Testing
- BioNIR Ridaforolimus Eluting Coronary Stent System
- Where
- Israel
- Volunteers
- 58 people
- Sponsor
- Medinol Ltd.
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Hypertrophic Cardiomyopathy, Sudden Cardiac Death
PRecIsion Medicine in CardiomyopathY
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology.
- Trial name
- PRIMaCY (NCT04036799)
- Volunteers
- 572 people
- Sponsor
- The Hospital for Sick Children
Hypertrophic Cardiomyopathy
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and improving ventricular compliance.
- Trial name
- NCT05135871
- Testing
- Mavacamten
- Where
- China
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- LianBio LLC
Aortic Stenosis, Aortic Valve Stenosis
SAPIEN 3 Ultra EU PMS
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating…
- Trial name
- NCT04860752
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 37 sites in Austria, Finland and 8 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Cancer
Multiple Ascending Dose of BMS-911543
The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum…
- Trial name
- NCT01236352
- Testing
- BMS-911543
- Where
- 5 sites in United States, Australia
- Volunteers
- 98 people
- Sponsor
- Bristol-Myers Squibb
Primary Biliary Cholangitis, Primary Biliary Cirrhosis
Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis
The purpose of this open-label study is to evaluate the safety and tolerability of HDT1801 (BUDCA) over 12 weeks in adult subjects with PBC who have an inadequate response to standard therapy.
- Conditions
- Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Cholangitis, Cholestasis
- Trial name
- PRONTO-PBC (NCT04604652)
- Testing
- HTD1801 (BUDCA)
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Femoral Artery Stenosis, Femoral Artery Occlusion
Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
- Conditions
- Femoral Artery Stenosis, Femoral Artery Occlusion, Restenosis
- Trial name
- SFA ISR (NCT02063672)
- Testing
- Lutonix DCB, Standard Uncoated Balloon Angioplasty Catheter
- Where
- 20 sites in United States
- Volunteers
- 82 people
- Sponsor
- C. R. Bard
Aortic Stenosis
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.
- Trial name
- NCT01876420
- Testing
- The CoreValve™ Evolut R TAV™ system
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiovascular