Clinical trials: Vascular Device Occlusion
Coronary Artery Disease, Ischemic Heart Disease
LONG NAGOMI™ PMCF STUDY
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ _stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according…
- Trial name
- LONG NAGOMI (NCT07399002)
- Testing
- LONG NAGOMI
- Where
- 10 sites in Spain
- Volunteers
- 1,039 people
- Sponsor
- Fundación EPIC
Critical Lower Limb Ischemia, Critical Limb Ischemia
Evaluation of Carbothera in the Treatment of Foot Ulcers
Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with kidney disease.
- Conditions
- Critical Lower Limb Ischemia, Critical Limb Ischemia, Foot Ulcer, Skin Ulceration
- Trial name
- NCT02239419
- Testing
- CO2-Enriched Tap Water (Carbothera), Non-CO2-Enriched Tap Water
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- University of Manitoba
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
Hemorrhagic Stroke, Ischemic Stroke
Early Feasibility Study of the SENSE Device
A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset.
- Trial name
- NCT03827720
- Testing
- SENSE Device
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Sense Diagnostics, LLC
Arterial Occlusion, Cardiovascular Diseases
Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- NCT05468957
- Testing
- Perclose, Statseal
- Where
- 2 sites in United States
- Sponsor
- University of California, Los Angeles
CHD - Coronary Heart Disease, Angina, Stable
Coronary Microcirculatory and Bioresorbable Vascular Scaffolds
Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty).
- Conditions
- CHD - Coronary Heart Disease, Angina, Stable, Myocardial Ischemia
- Trial name
- EMPIRE-BVS (NCT03076476)
- Testing
- Bioresorbable Vascular Scaffolds (BVS), Drug-Eluting Stent (DES) - slow, Drug-Eluting Stent (DES) - standard(std)
- Where
- United Kingdom
- Volunteers
- 36 people
- Sponsor
- Papworth Hospital NHS Foundation Trust
Critical Limb Ischaemia, Claudication
Peripheral Vascular Disease and Nerve Stimulation
A study to see what effect the geko™ device has on blood flow in patients with lower limb vascular disease.
- Conditions
- Critical Limb Ischaemia, Claudication, Ulcers, Varicose Veins
- Trial name
- CCLINS (NCT01942941)
- Testing
- geko™ electrical stimulation
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hull University Teaching Hospitals NHS Trust
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
Brain Diseases, Cardiovascular Diseases
pRESET for Occlusive Stroke Treatment
Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion
- Conditions
- Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebrovascular Disorders
- Trial name
- PROST (NCT03994822)
- Testing
- Mechanical Thrombectomy using the pRESET Thrombectomy device, Mechanical Thrombectomy using the Solitaire Revascularization Device
- Where
- 24 sites in United States, Germany
- Volunteers
- 340 people
- Sponsor
- phenox Inc.
Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Validation of Two Wrist-worn Devices for the Assessment of Energy Expenditure in Cardiac Patients.
Improving physical activity is a core component of secondary prevention and cardiac (tele)rehabilitation. Commercially available activity trackers are frequently used to monitor and promote physical activity in cardiac patients.
- Trial name
- NCT03951740
- Testing
- Fitbit Charge 2, Mio Slice, Oxycon Mobile
- Where
- Netherlands
- Volunteers
- 39 people
- Sponsor
- Maxima Medical Center
Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention
Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.
This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as…
- Conditions
- Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention, Cardiovascular Disease Risk Factor, Coronary Artery Disease (CAD)
- Trial name
- BEACON-HEART (NCT07401550)
- Where
- Ireland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University College Dublin
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
Stable Ischemic Heart Disease, Coronary Artery Disease
Evaluation of Diagnostic Accuracy, Safety, and Cost-Effectiveness of the Non-Invasive Cardiolens FFR-CT Pro Method to Measure the Fractional Flow Reserve in Diagnostics of Chronic Coronary Syndromes Versus the Standard Diagnostic Modalities.
A multicentre, post-marketing, observational trial in 450 patients, whose standard diagnostic workup for chronic coronary syndromes provided for Invasive Coronary Angiography (ICA).
- Trial name
- NCT04777513
- Testing
- CCTA (Coronary Computed Tomography Angiography), ICA (Invasive Coronary Angiography), FFR (Fractional Flow Reserve)
- Where
- 11 sites in Poland
- Volunteers
- 450 people
- Sponsor
- Hemolens Diagnostics Sp. z o.o.
Atrial Fibrillation, Stroke, Ischemic
The Fourth Left Atrial Appendage Occlusion Study
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving…
- Conditions
- Atrial Fibrillation, Stroke, Ischemic, Systemic Embolism
- Trial name
- LAAOS-4 (NCT05963698)
- Testing
- WATCHMAN device
- Where
- 150 sites in United States, Belgium and 10 more
- Volunteers
- 4,000 people
- Sponsor
- Hamilton Health Sciences Corporation
Myocardiopathies, Ischemia, Myocardial
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.
- Conditions
- Myocardiopathies, Ischemia, Myocardial, Arrythmia, Death, Sudden, Cardiac
- Trial name
- EMMA (NCT00376532)
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Thomas Jefferson University
Coronary Artery Disease (CAD), Ischemic Heart Disease
ANGIOLITE PMCF Study ( rEPIC04F )
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Angiolite sirolimus eluting stent to meet EU Medical Device regulation (MDR)…
- Trial name
- rEPIC04F (NCT05292014)
- Testing
- ANGIOLITE
- Where
- 6 sites in Spain
- Volunteers
- 81 people
- Sponsor
- Fundación EPIC
Coronary Artery Lesions With Implantation of Coronary Device
REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice
A multicentre, observational, prospective device registry, with no control group, designed to evaluate the efficacy and safety of the bioresorbable coronary device, used according to the indications of use, in daily clinical…
- Trial name
- REPARA (NCT02256449)
- Where
- Spain
- Volunteers
- 2,440 people
- Sponsor
- Sección Hemodinamica y Cardiologia Intervencionista
Coronary Artery Disease
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for distal embolism in Acute coronary syndrome(ACS).
- Trial name
- VAMPIRE3 (NCT01460966)
- Testing
- Filtrap™ + Thrombus aspiration catheter, Thrombus aspiration catheter
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Yokohama City University Medical Center
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.
Atrial Fibrillation, Left Atrial Appendage Thrombosis
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF
The primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased…
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Thrombosis, CVA
- Trial name
- CORRAL-AF (NCT04684212)
- Testing
- LAmbre PlusTM Left Atrial Appendage Closure System, Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
- Where
- United States
- Sponsor
- Brian O'Neill MD