Clinical trials: Vascular Closure, active
Intracerebral Hemorrhage, Atrial Fibrillation
Avoiding Anticoagulation After IntraCerebral Haemorrhage
Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF).
- Conditions
- Intracerebral Hemorrhage, Atrial Fibrillation, Microhaemorrhage
- Trial name
- A3ICH (NCT03243175)
- Testing
- Apixaban 5 MG, left atrial appendage closure
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Lille
Femoral Access Site Closure, Ambulation
Time to Ambulation After ProGlide Closure
Transradial access has become the standard for coronary procedures due to fewer vascular complications and shorter bed rest, yet transfemoral access remains essential for complex peripheral interventions requiring larger sheaths…
- Conditions
- Femoral Access Site Closure, Ambulation, Vascular Access Complication, Vascular Access Site Management
- Trial name
- OPTIMA (NCT07179536)
- Testing
- Ambulation after ProGlide Closure
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Vascular Closure Device
The Ladera Suture-Mediated Large Bore Closure Pivotal Study
The study objective is to demonstrate the safety and efficacy of the investigational device to achieve hemostasis of common femoral artery access sites in participants undergoing percutaneous interventional catheterization…
- Trial name
- FASTEN II (NCT07541235)
- Testing
- Ladera LBC System
- Where
- Australia
- Volunteers
- 214 people
- Sponsor
- Ladera Medical
Leg Ulcers, Leg Ulcers Venous
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Chronic lower limb ulcers, particularly those of venous etiology, are difficult-to-heal wounds that severely affect patients' quality of life. Adequate tissue oxygenation is essential for wound healing.
- Trial name
- NCT07901517
- Testing
- Vacuum Compression Therapy (VCT), Standard Wound Care
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- BTL Industries Ltd.
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
Femoral Artery Puncture, Vascular Closure Device
Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture.
- Conditions
- Femoral Artery Puncture, Vascular Closure Device, Hemostasis
- Trial name
- NCT07279220
- Testing
- Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd., MynxGrip Vascular Closure Device Manufactured by Cordis US Corp
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
Atrial Fibrillation, Stroke
Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage
Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis.
- Conditions
- Atrial Fibrillation, Stroke, Intracerebral Hemorrhage
- Trial name
- NCT02830152
- Testing
- LAAO, Medical Therapy
- Where
- 17 sites in Denmark, Finland and 2 more
- Volunteers
- 750 people
- Sponsor
- Karolinska Institutet
Atrial Fibrillation, Atrial Appendage
AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation, Atrial Appendage, Anticoagulants, Stroke
- Trial name
- APPENDAGE (NCT04796714)
- Testing
- Double antiplatelet therapy, Aspirin, Brain MRI
- Where
- 2 sites in France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Bordeaux
Chronic Venous Insufficiency, CVI, Venous Malformations
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the…
- Conditions
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome
- Trial name
- HIFIVE (NCT06642051)
- Testing
- High Intensity focused ultrasound
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sonablate
Vascular Closure Devices
xDot Access Management System Pivotal Study
The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure.
- Trial name
- NCT07719244
- Testing
- xDot Access Management System (AMS)
- Volunteers
- 266 people
- Sponsor
- xDot Medical, Inc
Non-valvular Atrial Fibrillation, Embolic Stroke
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System.
- Trial name
- NCT04559243
- Testing
- Transthoracic Echocardiography
- Where
- 5 sites in China
- Volunteers
- 579 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Patent Foramen Ovale, Atrial Arrhythmia
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have…
- Conditions
- Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke
- Trial name
- AFLOAT (NCT05213104)
- Testing
- Flecainide
- Where
- France
- Volunteers
- 186 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Vascular Closure Devices
xDot Access Management System Early Feasibility Study
The objective of this study is to demonstrate safety and investigate effectiveness of the xDot Access Management System (AMS) for closure of large bore femoral-arterial and femoral-venous access sites.
- Trial name
- NCT07464353
- Testing
- xDot Access Management System (AMS)
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- xDot Medical, Inc
Vascular Closure Device, Femoral Arteriotomy Closure
Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)
This study evaluates the safety and effectiveness of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional…
- Conditions
- Vascular Closure Device, Femoral Arteriotomy Closure, Femoral Access Site Closure
- Trial name
- NCT07862309
- Testing
- Novelrad Vascular Closure System (NVCS)
- Volunteers
- 65 people
- Sponsor
- Novelrad Ltd.
Ischemic Stroke, Embolic Stroke of Undetermined Source
SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Patent foramen ovale (PFO) is an important mechanism of embolic stroke of undetermined source (ESUS). Current guidelines recommend PFO closure for high-risk PFO in patients younger than 60 years, and a recent retrospective cohort…
- Conditions
- Ischemic Stroke, Embolic Stroke of Undetermined Source, Patent Foramen Ovale (PFO), Elderly
- Trial name
- SENIOR (NCT07479147)
- Testing
- PFO closure, Medication
- Where
- 3 sites in Taiwan
- Volunteers
- 400 people
- Sponsor
- Taichung Veterans General Hospital
Septic Shock
Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock
This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock.
- Trial name
- NCT07603024
- Testing
- Shenfu Injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- First Affiliated Hospital of Wannan Medical College
Patent Foramen Ovale, Cryptogenic Stroke
Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Older Patients, Medical Treatment
- Trial name
- STOP (NCT05907694)
- Testing
- Transcatheter PFO closure, Optimal medical treatment
- Where
- 2 sites in Canada
- Volunteers
- 714 people
- Sponsor
- Josep Rodes-Cabau
Atrial Fibrillation, Stroke
SIMPLAAFY Clinical Trial
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- SIMPLAAFY (NCT06521463)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 86 sites in United States
- Volunteers
- 1,857 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Venous Closure System After AF Ablation
This prospective, randomized, participant-blinded study will compare a suture-based venous closure system (Perclose ProGlide™) with a conventional figure-of-8 suture for femoral venous access-site closure in patients undergoing…
- Trial name
- NCT07814144
- Testing
- Perclose ProGlide™, Figure-of-8 suture
- Where
- South Korea
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Atrial Fibrillation (AF), Stroke
Elite AF IDE Trial (Elite AF)
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for…
- Trial name
- NCT07287436
- Testing
- WATCHMAN Elite LAAC Device
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation