Clinical trials: Vascular; Lesion, Central Nervous System
Central Nervous System (CNS) Lesions, Brain Metastases
Phase 2 Ascending Dose Safety and Efficacy Study of RVP-001, a Manganese-based MRI Contrast Agent
This Phase 2 clinical trial will study RVP-001, a new manganese-based MRI contrast agent, in people who are known to have gadolinium-enhancing central nervous system (CNS) lesions, for example brain tumors or multiple sclerosis.
- Conditions
- Central Nervous System (CNS) Lesions, Brain Metastases, Brain Neoplasms, Brain Neoplasms, Benign
- Trial name
- NCT06322342
- Testing
- RVP-001
- Where
- 5 sites in United States
- Volunteers
- 18 people
- Sponsor
- Reveal Pharmaceuticals Inc.
Angina Pectoris
A Prospective, Single-arm, Multi-centre, Observational, Real World Registry
A prospective, single-arm, multi-centre, observational, real world registry to evaluate safety and performance of the BioMime™ Morph Sirolimus Eluting Coronary Stent System for very long coronary lesions.
- Trial name
- Morpheus (NCT02901353)
- Testing
- Sirolimus Eluting Coronary Stent System
- Where
- 5 sites in Hungary, Jordan and 2 more
- Volunteers
- 400 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Acute Ischemic Stroke
MRI-based Artificial Intelligence Software (NNS-SOT) for Onset Time Estimation in Lesion With Acute Ischemic Stroke
This study evaluates the efficacy of investigational device named Stroke Onset Time Artificial Intelligence(AI) (Model name:NNS-SOT).
- Trial name
- NCT06160726
- Where
- South Korea
- Volunteers
- 474 people
- Sponsor
- Nunaps Inc
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
Acute Ischemic Stroke Patients
Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients.
The clinical trial is for acute ischemic stroke patients measuring cerebral oxygen saturation (rSO2) values using pulse oximeter of near-infrared spectroscopy in the frontal lesion area and normal area of brain.
- Trial name
- fNIRS (NCT06250608)
- Testing
- Pulse oximeter, NIRSITX
- Where
- 2 sites in South Korea
- Volunteers
- 35 people
- Sponsor
- OBELAB, Inc.
Coronary Artery Disease
SELUTION 4 De Novo Small Vessel IDE Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as…
- Trial name
- NCT05946629
- Testing
- PCI with SELUTION SLR DCB, PCI with FDA approved "-limus" DES
- Where
- 70 sites in United States, Belgium and 1 more
- Volunteers
- 960 people
- Sponsor
- M.A. Med Alliance S.A.
Carotid Artery Stenosis
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
Clinical Trial Summary Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Trial name
- CREATE (NCT06936176)
- Testing
- Neurovascular Intravascular Shockwave Catheter
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Dementia, Parkinson Disease
Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera
This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera.
- Conditions
- Dementia, Parkinson Disease, Pulmonary Hypertension, Heart Diseases
- Trial name
- NCT03438123
- Testing
- CZT SPECT imaging
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Spectrum Dynamics
Moderate to Severe Acute Lower Back Pain
Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute lower back pain.
- Trial name
- NCT05096494
- Testing
- SP-103
- Where
- 10 sites in United States
- Volunteers
- 76 people
- Sponsor
- Scilex Pharmaceuticals, Inc.
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-V (NCT02389946)
- Testing
- Orsiro DES, Xience DES
- Where
- 92 sites in United States, Australia and 11 more
- Volunteers
- 1,334 people
- Sponsor
- Biotronik, Inc.
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Stroke, Craniocerebral Trauma
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g.
- Trial name
- NCT00860210
- Testing
- Neurostep™ System
- Where
- 4 sites in Canada, India and 1 more
- Volunteers
- 14 people
- Sponsor
- Neurostream Technologies G.P.
Suspected Arrhythmia, Palpitations
This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or Transient
This exploratory medical device study evaluated the arrhythmia diagnostic yield of MEMO Patch V2, a wearable patch-type electrocardiographic monitor, in adults with suspected arrhythmia who presented with symptoms such as…
- Conditions
- Suspected Arrhythmia, Palpitations, Dizziness, Cryptogenic Ischemic Stroke
- Trial name
- NCT07722026
- Testing
- MEMO Patch V2, 24-Hour Holter Monitor
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- HUINNO Co., Ltd
Acute Ischemic Stroke
Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
- Trial name
- SPLENDID (NCT06386289)
- Testing
- Cereglide 92
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Acute Ischemic Stroke
Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke
The purpose of this study is to identify a safe and effective bolus dose of intra-arterial/intra-thrombus alfimeprase in acute ischemic stroke (AIS) 3 to 9 hours from symptom onset.
- Trial name
- NCT00499902
- Testing
- alfimeprase
- Where
- 22 sites in United States, Canada
- Volunteers
- 7 people
- Sponsor
- ARCA Biopharma, Inc.
Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Microvention AnEurysm & STroke Real-life Data cOllection
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
- Conditions
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke
- Trial name
- MAESTRO (NCT06494436)
- Testing
- All Microvention Class III implantable device CE marked, All Microvention Mechanical Thrombectomy Class III device CE marked
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Atherosclerosis
An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.
- Trial name
- IRISS (NCT00929383)
- Testing
- Wingspan Stent System with Gateway PTA Balloon Catheter
- Where
- 19 sites in France, Germany
- Volunteers
- 82 people
- Sponsor
- Stryker Neurovascular
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple…
- Trial name
- NCT00330759
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 1,779 people
- Sponsor
- Amgen
Angiofibroma of Face, Tuberous Sclerosis
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex
The objective of this study is to evaluate the safety and efficacy of sirolimus (0.2% and 0.4% formulations) and its vehicle when applied topically once daily for 12 weeks for the treatment of cutaneous angiofibromas in pediatric…
- Trial name
- NCT03363763
- Testing
- Sirolimus 0.2%, Sirolimus 0.4%
- Where
- 8 sites in United States, China
- Volunteers
- 24 people
- Sponsor
- Aucta Pharmaceuticals, Inc