Clinical trials: Vascular Closure
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.
Vascular Closure Device, Femoral Arteriotomy Closure
Initial Safety and Preliminary Efficacy of the Novelrad Vascular Closure System (NVCS)
This study evaluates the initial safety and preliminary efficacy of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing…
- Conditions
- Vascular Closure Device, Femoral Arteriotomy Closure, Femoral Access Site Closure
- Trial name
- NCT07858903
- Testing
- Novelrad Vascular Closure System (NVCS)
- Where
- 3 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novelrad Ltd.
Venous Vascular Closure, Electrophysiology Study
Mobilization and Outcomes After Venous Closure
The primary objective of this post-market registry is to collect real-world outcomes and evaluate usage practice of MYNX CONTROL™ VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F in sealing femoral venous access sites in…
- Trial name
- MOVE (NCT07246902)
- Testing
- MYNX CONTROLTM VENOUS Vascular Closure Device
- Where
- 9 sites in United States
- Volunteers
- 339 people
- Sponsor
- Cordis US Corp.
Atrial Fibrillation, Atrial Septal Defect
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
The purpose of this study is to evaluate the clinical efficacy and safety of the Perclose ProStyle™ Suture-Mediated Closure Device in patients undergoing cardiologic procedures via a femoral vein approach using a sheath size of 8…
- Conditions
- Atrial Fibrillation, Atrial Septal Defect, Vascular Closure Device
- Trial name
- Eight-CLOVER (NCT07827287)
- Testing
- Perclose ProStyle™ Suture-Mediated Closure System, Conventional Hemostasis (Manual Compression or Figure-of-Eight Suture)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Ewha Womans University Mokdong Hospital
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 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
Vascular Closure, Femoral Arteriotomy Closure
The Ladera Suture-Mediated Large Bore Closure Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- FASTEN (NCT06851481)
- Testing
- Ladera LBC System
- Where
- 6 sites in Australia, Belgium and 1 more
- Volunteers
- 55 people
- Sponsor
- Ladera Medical
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
Vascular Closure, Pacemaker Implantation
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker…
- Conditions
- Vascular Closure, Pacemaker Implantation, Leadless Pacemaker
- Trial name
- PERCLOSE-LP (NCT06837870)
- Testing
- percutaneous suture mediated closure, Figure of Eight Suture
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Massachusetts, Worcester
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, Femoral Arteriotomy Closure
The Ladera Large Bore Closure Feasibility Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- NCT06358157
- Testing
- Ladera LBC System
- Where
- 3 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Ladera Medical
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
Vascular Closure
Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
- Trial name
- NCT03756558
- Testing
- Cross-Seal System
- Where
- 20 sites in United States
- Volunteers
- 147 people
- Sponsor
- Terumo Medical Corporation
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
Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair
GLYCAR Post Market Multicenter Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Trial name
- CIP002 (NCT05661981)
- Testing
- GLYCAR Pericardial Patch
- Where
- 4 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- GLYCAR SA (Pty) Ltd
Venous Vascular Closure
Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression
ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs.
- Trial name
- ReliaSeal (NCT05554471)
- Testing
- MYNX CONTROL™ Venous Vascular Closure Device 6F-12F
- Where
- 14 sites in United States
- Volunteers
- 352 people
- Sponsor
- Cordis US Corp.
Percutaneous Large Hole Vascular Closure
PerQseal® Clinical Study
The objective is to evaluate the safety and effectiveness of the PerQseal vascular closure device system when used to achieve haemostasis of common femoral arteriotomies created by 12 to 22 F sheaths (arteriotomy up to 26 F) in…
- Trial name
- PATCH (NCT05653336)
- Testing
- PerQseal® Closure Device System
- Where
- 18 sites in United States, Germany
- Volunteers
- 149 people
- Sponsor
- Vivasure Medical Limited
Percutaneous Large Hole Vascular Closure
PerQseal® Impella Early Feasibility Study
The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population.
- Trial name
- NCT04818541
- Testing
- PPCI, Cardiogenic shock
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Vivasure Medical Limited
Percutaneous Large Hole Vascular Closure
PerQseal®+ Early Feasibility Study
The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral…
- Trial name
- NCT05163548
- Testing
- PerQseal Plus Device
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Vivasure Medical Limited
Vascular Closure, Endovascular Procedure
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- NCT05335525
- Testing
- Closure of the femoral arterial puncture site
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.