Clinical trials: Femoral Access Site Closure
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
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.
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
Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual…
- Trial name
- NCT00842179
- Where
- United States
- Volunteers
- 2,517 people
- Sponsor
- Clinyx, LLC
Arterial Closure Device, Percutaneous Coronary Intervention (PCI)
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.
- Conditions
- Arterial Closure Device, Percutaneous Coronary Intervention (PCI), Access Site Bleeding, Adverse Cardiac Events
- Trial name
- FERARI (NCT02455661)
- Testing
- TR Band (TM), AngioSeal, StarClose
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Universitätsmedizin Mannheim
Arrhythmia
Perclose Multi-Access Duplex Ultrasound (DUS) Study
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and…
- Trial name
- NCT04904809
- Testing
- Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Abbott Medical Devices
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.
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, Inc.
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
Hemostasis,Surgical
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.
- Trial name
- NCT00507013
- Testing
- QuickClose device
- Where
- Israel
- Volunteers
- 8 people
- Sponsor
- CardioDex
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 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.
Aortic Stenosis
Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure
The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)
- Trial name
- NCT07205068
- Testing
- Shockwave M5 IVL Catheter, Modified Seldinger Technique
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Tennessee Graduate School of Medicine
Cardiac Diagnostic Procedure, Cardiac Interventional Procedure
The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.
- Conditions
- Cardiac Diagnostic Procedure, Cardiac Interventional Procedure, Femoral Access Site Closure
- Trial name
- NCT02438475
- Testing
- Mynx Vascular Closure System, Manual Compression
- Where
- 2 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Medstar Health Research Institute
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.
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients
The most frequent access site for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the common femoral artery (CFA), using either an open or percutaneous technique.
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Myocarditis, Hypertension, Pulmonary
- Trial name
- NCT04689451
- Volunteers
- 40 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Bleeding
Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with…
- Trial name
- NCT01873898
- Testing
- Rex Medical Closer™ Vascular Closure System
- Where
- Paraguay
- Volunteers
- 30 people
- Sponsor
- Rex Medical
Coagulation, Therapeutic Uses
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System
The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device.
- Conditions
- Coagulation, Therapeutic Uses, Pharmacologic Actions
- Trial name
- NCT01121510
- Testing
- closure device
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CardioDex
The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal
Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System
It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at…
- Trial name
- NCT01597570
- Testing
- Vascular Closure Device
- Where
- 2 sites in South Korea
- Volunteers
- 52 people
- Sponsor
- Taewoong Medical Co., Ltd.