Clinical trials: Stricture
Aortic Valve Insufficiency, Aortic Valve Stenosis
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
- Trial name
- NCT05172973
- Testing
- SAPIEN X4/X4S THV
- Where
- 37 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
The Leaflex™ Early Feasibility Study
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04636073
- Testing
- Leaflex™ Performer
- Sponsor
- Pi-cardia
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
This is a prospective, open label, multicenter, single arm, first in human clinical study. Patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be enrolled.
- Trial name
- CHAMPIONSHIP (NCT06410313)
- Testing
- ChampioNIR Ridaforolimus Eluting Peripheral Stent System
- Where
- 7 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- Medinol Ltd.
Arteriovenous Fistula
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous…
- Trial name
- NCT04261686
- Testing
- Covera Vascular Covered Stent
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
Intracranial Atherosclerosis
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
- Trial name
- NCT05757505
- Testing
- Intracranial Stent (Tonbridge), Wingspan Stent System (Stryker Neurovascular)
- Where
- 13 sites in China
- Volunteers
- 200 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
Coronary Artery Disease, Heart Disease, Ischemic
Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease
This is a prospective, non-randomized, open label, multi-center study including 60 patients with symptomatic ischemic heart disease with 70%-100% coronary artery stenoses and occlusions enrolled and treated in this…
- Conditions
- Coronary Artery Disease, Heart Disease, Ischemic, Coronary Stenosis
- Trial name
- NCT03301246
- Testing
- Artimes Pro Low Profile Dilatation Catheter
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Eminence Clinical Research, Inc.
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular
Urethral Stricture
Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
- Trial name
- STREAM (NCT05383274)
- Testing
- Optilume Urethral DCB
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- Urotronic Inc.
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
Carotid Stenosis
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated…
- Trial name
- SONOMA (NCT00478673)
- Testing
- NexStent Carotid Stent System (Monorail Delivery System), FilterWire EZ™ Embolic Protection System
- Where
- 62 sites in United States
- Volunteers
- 298 people
- Sponsor
- Boston Scientific Corporation
Coronary Stenosis
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)
The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared…
- Trial name
- POLBOS-LM (NCT03508219)
- Testing
- BiOSS LIM C
- Where
- 15 sites in France, Italy and 1 more
- Volunteers
- 130 people
- Sponsor
- ECRI bv
Aortic Valve Disease, Aortic Valve Stenosis
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Regurgitation
- Trial name
- NCT06518681
- Testing
- PoliaValve (Aortic)
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
The MOTION Study - Treatment of LSS With the MILD Procedure
Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional…
- Trial name
- NCT03610737
- Testing
- MILD Procedure, Conventional Medical Management (CMM)
- Where
- 18 sites in United States
- Volunteers
- 155 people
- Sponsor
- Vertos Medical, Inc.
Coronary Artery Stenosis
Kidney Damage In Patients With Severe Fall In eGFR
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI).
- Trial name
- NCT01136915
- Testing
- Iopamidol 370, Iodixanol 320
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Bracco Diagnostics, Inc
Hypertrophic Cardiomyopathy
A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada
This real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the Bristol-Myers Squibb (BMS)-sponsored…
- Trial name
- NCT06549608
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 683 people
- Sponsor
- Bristol-Myers Squibb
Coronary Artery Disease, Native Coronary Artery Stenosis
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
- Trial name
- MAGICAL SV (NCT06271590)
- Testing
- Sirolimus Drug Coated Balloon, Drug eluting stents (DES)
- Where
- 24 sites in United States
- Volunteers
- 1,605 people
- Sponsor
- Concept Medical Inc.
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) versus placebo in adults with symptomatic hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction.
- Trial name
- SEQUOIA-HCM (NCT05186818)
- Testing
- Aficamten (5 mg, 10 mg, 15 mg, and 20 mg)
- Where
- 114 sites in United States, China and 12 more
- Volunteers
- 282 people
- Sponsor
- Cytokinetics
Spinal Stenosis
Intermittent Neurogenic Claudication Treatment With APERIUS®
The primary purpose of the study is to measure the change in severity of symptoms and ability to function in every day activities in patients suffering from degenerative lumbar spinal stenosis after treatment with the Aperius®…
- Trial name
- INCA (NCT00887744)
- Testing
- Aperius® Percutaneous Interspinous Spacer
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 162 people
- Sponsor
- Medtronic Spinal and Biologics
Aortic Valve Stenosis
A Study to Evaluate the Neuro-embolic Consequences of TAVR
A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT02073864
- Where
- 5 sites in United States
- Volunteers
- 46 people
- Sponsor
- Keystone Heart
Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- TRANSFORM™ (NCT01700439)
- Testing
- EDWARDS INTUITY valve
- Where
- 29 sites in United States
- Volunteers
- 934 people
- Sponsor
- Edwards Lifesciences