Clinical trials: Atherosclerosis
Peripheral Arterial Disease
Study of NMB Drug Ejecting Balloon for Peripheral Arteries
The purpose of this study is to demonstrate the Safety and effectiveness of the use of NMB's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.
- Trial name
- NCT01646801
- Testing
- NMB Balloon Catheter
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- N.M.B. Medical Applications Ltd
Cardiovascular Diseases, Smoking
Effect of Switching From Cigarette Smoking to THS on Systemic Endothelial Function in Subjects With Established Atherosclerotic Disease
The purpose of this study is to demonstrate improvement in flow mediated dilation (FMD), a functional endpoint associated with the progression of atherosclerosis, when switching from cigarettes to the Tobacco Heating System (THS)…
- Conditions
- Cardiovascular Diseases, Smoking, Tobacco Use, Peripheral Arterial Disease
- Trial name
- NCT05566678
- Testing
- Cigarette, THS, Smoking Abstinence
- Sponsor
- Philip Morris Products S.A.
Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or…
- Conditions
- Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease
- Trial name
- NCT01961167
- Testing
- Stenting of common and/or external iliacs
- Where
- New Zealand
- Volunteers
- 27 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease (PAD)
A Study to Evaluate the Safety and Effectiveness of the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System in Adults With Peripheral Artery Disease (PAD)
The purpose of this clinical study is to learn if the FastWave Artero™ Peripheral Intravascular Lithotripsy (IVL) System is safe and works well to help people with peripheral artery disease (PAD) who have hard, calcium-filled…
- Trial name
- SPARC (NCT07209085)
- Testing
- FastWave Artero™ Peripheral IVL System
- Volunteers
- 110 people
- Sponsor
- FastWave Medical
Hypercholesterolemia
Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)
A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C
- Trial name
- NCT04765657
- Testing
- inclisiran sodium
- Where
- 45 sites in China, Singapore and 2 more
- Volunteers
- 345 people
- Sponsor
- Novartis Pharmaceuticals
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
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
Peripheral Arterial Disease
Evaluation of the Pantheris Atherectomy System
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased…
- Trial name
- VISION (NCT01937351)
- Testing
- Pantheris System
- Where
- 21 sites in United States, Germany
- Volunteers
- 162 people
- Sponsor
- Avinger, Inc.
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.
Peripheral Arterial Disease
A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD
The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).
- Trial name
- Concerto (NCT05100745)
- Testing
- Therapeutic Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Vibrato Medical, Inc.
Atherosclerotic Cardiovascular Disease
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that…
- Trial name
- NCT04992065
- Testing
- NNC0385-0434 A 15 mg, NNC0385-0434 A 40 mg, NNC0385-0434 A 100 mg
- Where
- 44 sites in United States, Belgium and 5 more
- Volunteers
- 267 people
- Sponsor
- Novo Nordisk A/S
Peripheral Artery Disease
Effect of Neo40 on PAD
Reduced nitric oxide (NO) availability is a hallmark of a number of cardiovascular diseases (CVD) including peripheral artery disease (PAD).
- Trial name
- NCT02934438
- Testing
- Neo40
- Volunteers
- 30 people
- Sponsor
- HumanN
Peripheral Arterial Disease, Arterial Puncture
The Safety and Efficacy of the Suture-Mediated Closure System
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the…
- Trial name
- NCT05841836
- Testing
- the Suture-Mediated Closure System, Perclose ProGlide Suture-Mediated Closure System
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
Critical Limb Ischemia
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.
- Trial name
- NCT01472289
- Testing
- Autologous Bone Marrow Mononuclear cells (BMMNCs)
- Where
- India
- Volunteers
- 17 people
- Sponsor
- TotipotentSC Scientific Product Pvt. Ltd.
Peripheral Arterial Disease
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the…
- Trial name
- Axys ACHIEVE (NCT04282161)
- Testing
- Axys EX device
- Sponsor
- Medtronic Endovascular
Peripheral Arterial Disease, Calcifications Vascular
SOLUTION Trial in China
This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
- Trial name
- NCT05434676
- Testing
- Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System M5 & S4
- Where
- 5 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Peripheral Arterial Disease
DOTAREM®-Enhanced MRA Compared to GADOVIST®-Enhanced MRA in Patients With Abdominal or Lower Limb Arterial Diseases
This study is an intra-individual comparison of DOTAREM®-enhanced MRA and GADOVIST®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
- Trial name
- NCT00955617
- Testing
- Contrast-enhanced MRA - Imaging examination
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Guerbet
Peripheral Arterial Disease (PAD)
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries.
- Trial name
- NCT00707876
- Testing
- ferumoxytol
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Peripheral Artery Disease
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.
- Trial name
- NCT00676494
- Testing
- Pathway PV Atherectomy System
- Volunteers
- 172 people
- Sponsor
- Pathway Medical Technologies Inc.