Clinical trials: Vascular Closure, open to volunteers
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, 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
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.
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 (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
Atrial Fibrillation, Stroke
Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed…
- Trial name
- NCT05464511
- Testing
- Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Coronary Artery Disease
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion…
- Trial name
- CALAMBRE (NCT07260474)
- Testing
- Patients implanted with Amplatzer Amulet™, Patients implanted with LAmbre™
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Fundación EPIC
Diabetic Foot Ulcer
Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds
Singapore has one of the world's highest diabetes-related lower limb amputation rates in the world. Between 2008 - 2017, 4724/5306 (89.0%) of all major amputations and 6656/7227 (92.1%) of all toe/ray amputations performed in…
- Trial name
- NCT06832787
- Testing
- Negative Pressure Wound Therapy, Kerecis, Delayed primary closure with local flap
- Where
- 2 sites in Singapore
- Volunteers
- 75 people
- Sponsor
- Singapore General Hospital
Patent Foramen Ovale, Ischemic Stroke
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Bleeding Ulcer
- Trial name
- HALTI (NCT04475510)
- Testing
- Antiplatelet treatment discontinuation
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Josep Rodes-Cabau
Carotid Arteriosclerosis, Carotid Stenosis
Residual Stenosis and Restenosis Following Carotid Endarterectomy With Primary Closure, A Prospective Tracking Study
This prospective, multicenter observational study aims to evaluate the incidence, timing, and characteristics of residual and recurrent (restenosis) carotid artery stenosis following carotid endarterectomy (CEA) with primary…
- Conditions
- Carotid Arteriosclerosis, Carotid Stenosis, Brain Stroke
- Trial name
- RECEPT (NCT07057297)
- Where
- Czechia
- Volunteers
- 300 people
- Sponsor
- Charles University, Czech Republic