Clinical trials: Vascular Device Occlusion
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
Acute Ischemic Stroke
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)
To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction (within 8 hours after onset), in whom intravenous…
- Trial name
- TRON1-Japan (NCT02964702)
- Testing
- Thrombectomy Device T-01
- Where
- 13 sites in Japan
- Volunteers
- 50 people
- Sponsor
- JIMRO Co., Ltd.
Coronary Artery Disease, Stable Angina
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
- Trial name
- NCT07763769
- Testing
- MedHub AutocathFFR
- Where
- 4 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medhub Ltd.
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.
Peripheral Arterial Disease
Safety and Efficacy Study of a New Intermittent Pneumatic Compression Device to Treat Patients With Peripheral Arterial Disease (PAD) Stage II
The purpose of this study is to evaluate the safety and efficacy of new intermittent pneumatic compression device on initial claudication distance in patients with Peripheral Arterial Disease stage II
- Trial name
- NCT00762086
- Testing
- AngioPress Intermittent pneumatic compression (IPC) Device, Medications and Standard walking exercises
- Where
- 4 sites in Germany, Israel
- Volunteers
- 67 people
- Sponsor
- Mego Afek Ltd.
Stents, Coronary Artery Disease
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V®…
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis
- Trial name
- NCT00180479
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 1,002 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Myocardial Ischaemia
SeQuent® SCB "All Comers" Post Market Clinical Follow-up (PMCF)
The aim of the study is to assess continued safety and efficacy of the SeQuent® SCB. The product under investigation will be used in routine clinical practice according to the latest European Society of Cardiology (ESC)…
- Trial name
- SCORE (NCT04470934)
- Testing
- SeQuent® SCB drug-coated balloon catheter
- Where
- Germany
- Volunteers
- 1,302 people
- Sponsor
- B. Braun Melsungen AG
Peripheral Arterial Disease
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
- Trial name
- PRELUDE (NCT03001700)
- Testing
- Serranator™ Alto PTA Serration Balloon Catheter
- Where
- 4 sites in Austria, New Zealand and 1 more
- Volunteers
- 25 people
- Sponsor
- Cagent Vascular LLC
Stroke, Ischemic
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial…
- Trial name
- NCT03464565
- Testing
- Penumbra System
- Where
- 42 sites in United States, France and 4 more
- Volunteers
- 650 people
- Sponsor
- Penumbra Inc.
Thrombosis, Venous Thrombosis
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
- Trial name
- NCT00346424
- Testing
- Alfimeprase
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- ARCA Biopharma, Inc.
Peripheral Arterial Disease, Critical Limb Ischemia
The PRELUDE BTK Study
The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
- Trial name
- NCT03693963
- Testing
- Serranator
- Where
- 6 sites in Austria, Germany and 2 more
- Volunteers
- 49 people
- Sponsor
- Cagent Vascular LLC
Pulmonary Embolism, Medical Device Complication
Angel® Catheter Post Market Registry
This is a post-market, observational, retrospective multi-center Registry designed to gather information on the performance of the Angel® Catheter in general clinical practice.
- Conditions
- Pulmonary Embolism, Medical Device Complication, Deep Vein Thrombosis, Catheter Thrombosis
- Trial name
- NCT02917135
- Testing
- Angel® Catheter
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 2,000 people
- Sponsor
- BiO2 Medical
Coronary Artery Disease, High-risk Percutaneous Coronary Intervention
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI
The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High-risk Percutaneous Coronary Intervention, Interventional Cardiology
- Trial name
- NCT06087575
- Testing
- Supira System
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Supira Medical
Coronary Artery Disease
Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.
Patients with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure will be enrolled in the study.
- Trial name
- NCT04724057
- Testing
- AutocathFFR
- Volunteers
- 488 people
- Sponsor
- Medhub Ltd.
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, 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
Coronary Artery Disease
Rise Semi Compliant Balloon Study in Patient With CAD
Single arm, prospective, multi-center, trial designed to enrol approximately 66 patients. All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for…
- Trial name
- NCT04796038
- Testing
- Balloon dilatation
- Where
- 3 sites in Switzerland
- Volunteers
- 67 people
- Sponsor
- Biosensors Europe SA
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
Plug Arterial Closure System (PACS, 7F)
The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard…
- Trial name
- PACS 7F (NCT00533156)
- Testing
- Vascular access site closure (7F Ensure)
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Cordis US Corp.
Amputation Wound, Peripheral Arterial Disease
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.
- Trial name
- WISCR (NCT03611361)
- Testing
- SpectralMD DeepView Wound Imaging System 2.0
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- SpectralMD
Carotid Stenosis, Constriction, Pathologic
GORE Flow Reversal System and GORE Embolic Filter Extension Study
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders
- Trial name
- FREEDOM (NCT01343667)
- Testing
- Gore Flow Reversal System, Gore Embolic Filter
- Where
- 39 sites in United States
- Volunteers
- 1,397 people
- Sponsor
- W.L.Gore & Associates