Clinical trials: Atheromatosis
Peripheral Artery Disease, Peripheral Vascular Disease
Investigational Device Exemption Study to Determine the Safety and Efficacy of the Astron and Pulsar Stents
The objective of this study is to separately demonstrate the safety and efficacy of BIOTRONIK's Astron and Pulsar stents. The Pulsar stent will be used for the treatment of femoro-popliteal lesions, located in the native…
- Trial name
- BIOFLEX-I (NCT01319812)
- Testing
- Astron Stents, Pulsar Stents
- Where
- 35 sites in United States, Canada
- Volunteers
- 463 people
- Sponsor
- Biotronik, Inc.
Peripheral Arterial Disease
BioMimics 3D Stent Clinical Investigation: The Mimics Study
Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.
- Trial name
- Mimics (NCT02163863)
- Testing
- Femoropopliteal stenting
- Where
- Germany
- Volunteers
- 86 people
- Sponsor
- Veryan Medical Ltd.
Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in…
- Conditions
- Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia
- Trial name
- NCT05355402
- Testing
- Olezarsen
- Where
- 24 sites in United States, Canada
- Volunteers
- 154 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Atherosclerosis, Aneurysm
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.
- Trial name
- NCT00349908
- Testing
- Cordis Neurovascular ENTERPRISE Self Expanding Stent System
- Where
- Argentina
- Volunteers
- 20 people
- Sponsor
- Codman & Shurtleff
Atherosclerosis, Coronary Artery Disease
Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery…
- Trial name
- PTChina (NCT01285999)
- Testing
- PROMUS Element Coronary Stent System, TAXUS Liberté Coronary Stent System
- Where
- 15 sites in China
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Skin Cancer, Skin Diseases
Multi-modal Quantitative Imaging of the Skin
This clinical trial is about evaluating the suitability of multi-modal imaging technology, which covers virtually the entire body, to evaluate the possibility of screening and early detection of disease.
- Conditions
- Skin Cancer, Skin Diseases, Atopic Dermatitis, Psoriasis
- Trial name
- DermaFlow (NCT06989216)
- Where
- 3 sites in Sweden
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- HJN Sverige AB/Neko Health
Femoral Artery Stenosis, Popliteal Artery Stenosis
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery…
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- MDT-2113 SFA (NCT01947478)
- Testing
- MDT-2113 Drug-Eluting Balloon, Standard angioplasty balloon
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
Peripheral Arterial Disease
Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
To observe early safety and performance of the Shockwave Medical Lithoplasty® System (specifically, Lithoplasty® Catheters: 2.5 x 60mm, 2.75 x 60mm, 3.0 x 60mm, 3.25 x 60mm, and 3.5 x 60mm) in subjects to demonstrate that the…
- Trial name
- BTK (NCT02911623)
- Testing
- Shockwave Lithoplasty® System
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- Shockwave Medical, Inc.
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
Spectroscopic Assessment of Tissue Oxygenation Changes During Vascular Surgery
This study is a single-center, observational study designed to collect tissue spectrometric data related to tissue oxygenation.
- Conditions
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia Vascular, Tissue Ischemia
- Trial name
- NCT07786623
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Atherosclerotic Lesions in the Aortorenal Ostium
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.
The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic…
- Trial name
- RENAISSANCE (NCT00597142)
- Testing
- Express™ Renal Premounted Stent System
- Where
- 14 sites in United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Critical Limb Ischemia, Critical Lower Limb Ischemia
PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular…
- Conditions
- Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease
- Trial name
- PROMISE (NCT03970538)
- Testing
- LimFlow System
- Where
- 21 sites in United States, Puerto Rico
- Volunteers
- 105 people
- Sponsor
- LimFlow, Inc.
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Diabetic Foot, Critical Limb Ischemia
A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
The purpose of this study is to determine whether the method (implanting stem cells derived from peripheral blood after G-CSF mobilization) of treatment is safe and effective in the management of diabetic foot ischemia, the…
- Conditions
- Diabetic Foot, Critical Limb Ischemia, Leg Ulcers
- Trial name
- NCT00922389
- Testing
- will receive G-CSF and peripheral blood derived mononuclear cells, G-CSF, Standard Therapy
- Where
- India
- Volunteers
- 36 people
- Sponsor
- Beike Biotech India Pvt.ltd
Peripheral Artery Disease
Acotec DCB Post Market Clinical Follow-up
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical…
- Trial name
- FLOWER (NCT04393389)
- Testing
- AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
- Where
- 7 sites in Germany
- Volunteers
- 3,000 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Artery Disease
Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention: REACH PVI
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
- Trial name
- REACH PVI (NCT03943160)
- Testing
- Diamondback 360 Extended Length Orbital Atherectomy System
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Peripheral Artery Disease
AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal…
- Trial name
- NCT03267056
- Testing
- drug eluting balloon catheter (trade name: Orchid)
- Where
- 10 sites in China
- Volunteers
- 120 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Arterial Occlusive Disease, Critical Limb Ischemia
Safety, Tolerability, and Biodistribution of [89Zr]Zr-DFO-APAC in Subjects With PAOD/CLI and Healthy Volunteers (Acronyms: 89Zr = Zirconium-89, DFO = Desferrioxamine, APAC = AntiPlatelet AntiCoagulant, PET/CT = Positron Emission Tomography/Computed Tomography)
The goal of this Phase 0 clinical trial is to evaluate safety and biodistribution of [89Zr]Zr-DFO-APAC in patients with peripheral arterial occlusive disease / critical limb ischemia (PAOD/CLI) and healthy volunteers.
- Trial name
- CHASE (NCT06204237)
- Testing
- [89Zr]Zr-DFO-APAC, PET/CT scan
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Aplagon Oy
Peripheral Artery Disease, Arteriovenous Fistula Stenosis
FLEX Arteriovenous Access Registry
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
- Conditions
- Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis
- Trial name
- NCT04070365
- Testing
- FLEX Vessel Prep System followed by angioplasty
- Where
- 10 sites in United States
- Volunteers
- 114 people
- Sponsor
- VentureMed Group Inc.
Peripheral Artery Disease
BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions
BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions
- Trial name
- BIONETIC-I (NCT04830228)
- Testing
- Ballon expandable stent and PTA
- Where
- 15 sites in Austria, Belgium and 4 more
- Volunteers
- 160 people
- Sponsor
- Biotronik AG