Clinical trials: Vascular Closure Devices
Vascular Access Complications
Application of Vascular Closure Device in Transvenous Cardiac Intervention
Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery
- Trial name
- NCT05521100
- Testing
- Vascular closure device, figure eight stitch
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Shanghai 10th People's Hospital
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Clinical Study of the Medeon Biodesign XPro™
To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.
- Trial name
- NCT03171155
- Testing
- XPro System
- Where
- 6 sites in Australia, New Zealand and 1 more
- Volunteers
- 28 people
- Sponsor
- Medeon Biodesign, Inc.
Intracranial Hemorrhages, Atrial Fibrillation (AF)
Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.
Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke.
- Conditions
- Intracranial Hemorrhages, Atrial Fibrillation (AF), Atrial Flutter
- Trial name
- CLEARANCE (NCT04298723)
- Testing
- Percutaneous closure of the LAA (Watchman / Watchman FLX)
- Where
- 39 sites in Germany, Poland
- Volunteers
- 530 people
- Sponsor
- Jena University Hospital
Peripheral Vascular Diseases, Percutaneous Intervention Via Femoral Artery
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in…
- Trial name
- NCT05334095
- Testing
- Perclose ProGlide, Angio-seal VIP
- Where
- China
- Volunteers
- 1,062 people
- Sponsor
- Xiongjing Jiang
Atrial Fibrillation, Stroke
Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and…
- Trial name
- REFLX (NCT03339193)
- Testing
- Left atrial appendage closure
- Where
- United Kingdom
- Sponsor
- Oxford University Hospitals NHS Trust
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
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
Peripheral Vascular Disease, Coronary Artery Disease
Angio-Seal Evolution Device Registry
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
- Conditions
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease
- Trial name
- NCT00817349
- Where
- 10 sites in United States
- Volunteers
- 1,004 people
- Sponsor
- Abbott Medical Devices
Cardiac Disease, Coronary Artery Disease
Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who…
- Trial name
- NCT01600482
- Testing
- CELT ACD
- Where
- 5 sites in United States, Germany and 1 more
- Volunteers
- 241 people
- Sponsor
- Vasorum Ltd
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
Coronary Artery Disease
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention…
- Trial name
- ARISTOCRAT (NCT02061696)
- Testing
- Vascular Access Device, Standard Manual Compression
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Frank Saltiel
Femoral Arteriotomy Closure
MANTA Registry for Vascular Large-bore Closure
The aim of this observational post market study is to compile real world outcome data on the use of the Conformité Européenne (CE) marked MANTA Vascular Closure Device following percutaneous cardiac or peripheral procedures for…
- Trial name
- MARVEL (NCT03330002)
- Testing
- CE-marked MANTA vascular closure device (VCD)
- Where
- 9 sites in Canada, Denmark and 3 more
- Volunteers
- 500 people
- Sponsor
- Essential Medical, Inc.
Vascular Closure, Endovascular Procedure
Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- FEMOSEAL CLOSE (NCT05027698)
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Cardiovascular Disease
Same Day Versus Next Day Discharge: Ambulatory Closure Device Percutaneous Intervention
This is a multi-center trial that will evaluate the safety, feasibility, and cost effectiveness of discharging patients, who have had successful percutaneous coronary intervention (PCI) and deployment of the AngiomaxTM closure…
- Trial name
- ABCD-PCI (NCT01230606)
- Testing
- discharge vs. overnight stay
- Where
- 2 sites in United States
- Volunteers
- 303 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Noncommitted VSD
A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect
The purpose of this study is to investigate the security and validity of transesophageal echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in treatment of infundibular ventricular septal…
- Conditions
- Heart Septal Defects, Ventricular, Double Outlet Right Ventricle, Noncommitted VSD, Double Outlet Right Ventricle, Subaortic VSD, Double Outlet Right Ventricle, Subpulmonary VSD
- Trial name
- NCT02361008
- Testing
- TEE-guided perventricular device closure without CBP, Surgery repair with CBP
- Where
- China
- Volunteers
- 20,121,212 people
- Sponsor
- Bentong Yu
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
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot…
- Trial name
- Style-AF (NCT05563142)
- Testing
- deploying vascular closure device versus manual compression
- Where
- 3 sites in Germany
- Volunteers
- 125 people
- Sponsor
- University of Luebeck
Peripheral Arterial Disease
STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points.
- Trial name
- STEP (NCT03192033)
- Testing
- Arterial closure to ensure hemostasis at femoral artery puncture points, Proglide® (Abbott), Femoseal® (Terumo)
- Where
- 6 sites in France
- Volunteers
- 233 people
- Sponsor
- Nantes University Hospital
Vascular Closure, Endovascular Procedure
Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture
The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Femoral Artery
- Trial name
- NCT05822804
- Testing
- Vascular Closure Device (Tonbridge), EXOSEAL Vascular Closure Device (Codis Corporation)
- Where
- 7 sites in China
- Volunteers
- 228 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix