Clinical trials: Stenosis
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN Sub-study
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01182428
- Testing
- XIENCE V®/ XIENCE PRIME™, CYPHER SELECT
- Where
- 25 sites in Argentina, Austria and 13 more
- Volunteers
- 455 people
- Sponsor
- Abbott Medical Devices
Ischemic Stricture of Intestine
Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.
- Trial name
- ImpACT-1 (NCT03733236)
- Testing
- ISS Active Stimulation
- Where
- 2 sites in India
- Volunteers
- 98 people
- Sponsor
- BrainsGate
Angina, Chronic Coronary Occlusion
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the…
- Conditions
- Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- NCT01086228
- Testing
- XIENCE V / PROMUS stent
- Where
- 47 sites in Japan
- Volunteers
- 2,010 people
- Sponsor
- Abbott Medical Devices
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Stroke, Intracranial Atherosclerotic Stenosis
SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
This study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional therapy.
- Trial name
- SPINAS (NCT06047964)
- Testing
- DCB, POBA
- Where
- 9 sites in China
- Volunteers
- 281 people
- Sponsor
- B. Braun Medical International Trading Company Ltd.
Iliac Artery Stenosis
Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery
This is a multi-center, single arm, non-randomized, prospective clinical study using the Misago® RX Self-expanding Peripheral Stent for treatment of de novo, restenotic, and/or occlusive lesion(s) of the common and/or external…
- Trial name
- OSPREY ILIAC (NCT02793492)
- Testing
- Misago® RX Self-expanding Peripheral Stent
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Terumo Medical Corporation
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.
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, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Biliary Strictures Caused by Malignant Neoplasms
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary…
- Trial name
- NCT00713427
- Testing
- WallFlex™ Biliary Partially-Covered Stent
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Advanced Cancer, Various, NOS
Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or…
- Trial name
- NCT00884546
- Testing
- BMS-833923, Lenalidomide, Dexamethasone
- Where
- 8 sites in United States
- Volunteers
- 27 people
- Sponsor
- Bristol-Myers Squibb
Left Main Coronary Artery Stenosis
The OPTIMAL Randomized Controlled Trial
The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided…
- Trial name
- OPTIMAL (NCT04111770)
- Testing
- IVUS guided Percutaneous Coronary Intervention, Qualitative or quantitative angiography will guide percutaneous coronary intervention
- Where
- 28 sites in Italy, Spain and 1 more
- Volunteers
- 806 people
- Sponsor
- ECRI bv
Biliary Stricture, Biliary Anastomotic Stenosis
DIGEST I Drug Coated Balloon for Biliary Stricture
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
- Conditions
- Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease
- Trial name
- DIGEST (NCT03997994)
- Testing
- GIE Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 8 people
- Sponsor
- GIE Medical
Degenerative Disc Disease, Spinal Stenosis Lumbar
Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF).
- Conditions
- Degenerative Disc Disease, Spinal Stenosis Lumbar, Lumbar Spine Fusion, Spondylolisthesis
- Trial name
- NCT07775729
- Testing
- Allograft-derived growth factor (ProteiOS®), Standard of Care (SOC)
- Volunteers
- 280 people
- Sponsor
- Isto Biologics
Carotid Artery Stenosis
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
- Trial name
- NCT03816202
- Testing
- Sundt carotid shunt
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Lumbar Spinal Stenosis
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
- Trial name
- MiDAS I (NCT00956631)
- Testing
- Interlaminar Decompression
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Vertos Medical, Inc.
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
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
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.