Clinical trials: Vascular Closure Devices
Femoral Arteriotomy Closure
MANTA Percutaneous Vascular Closure Device - The SAFE MANTA Study
Research study which tests the safety and effectiveness of a new vascular closure device to close the femoral access puncture that is created in patients who require this form of access in order to perform the planned procedure.
- Trial name
- SAFE_MANTA (NCT02908880)
- Testing
- MANTA vascular closure device
- Where
- 19 sites in United States, Canada
- Volunteers
- 263 people
- Sponsor
- Essential Medical, Inc.
Percutaneous Common Femoral Artery Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral…
- Trial name
- FRONTIER-II (NCT02241642)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 65 people
- Sponsor
- Vivasure Medical Limited
Patients Requiring a Diagnostic and/or Interventional Diagnostic Procedure
St. Jude Medical Angio-Seal VIP Vascular Closure Device
The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.
- Trial name
- NCT01393041
- Testing
- Angio-Seal VIP
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
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 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
Percutaneous Closure of Arteriotomy in Common Femoral Artery
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE™ in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture…
- Trial name
- FRONTIER-I (NCT01943344)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- Ireland
- Volunteers
- 12 people
- Sponsor
- Vivasure Medical Limited
Diagnostic and/or Interventional Radiology Procedures
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient…
- Trial name
- NCT01222104
- Where
- 10 sites in United States
- Volunteers
- 634 people
- Sponsor
- Abbott Medical Devices
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
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
Percutaneous Closure of Artery Access Sites
InSeal VCD Large Bore Vascular Closure Device Safety and Effectiveness Clinical Study
The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.
- Trial name
- InSealVCD (NCT02628782)
- Testing
- InSeal's Vascular Closure Device
- Where
- 2 sites in Israel
- Volunteers
- 16 people
- Sponsor
- InSeal Medical Ltd.
Percutaneous Closure of Artery Access Sites
InSeal Vascular Closure Device Clinical Study Protocol
The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures.
- Trial name
- VCD (NCT01896401)
- Testing
- InSeal's Vascular Closure Device
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- InSeal Medical Ltd.
Hypertension
Efficacy of the New Closure Device in Improving Patient Compliance in Treatment of Hypertension With Valsartan+/-Hydrochlorothiazide (HCTZ) at 6 Months
This study will evaluate the efficacy of the reminder device Remind Cap® in improving patients' compliance in the consumption of Valsartan +/- Hydrochlorothiazide (HCTZ) in the treatment of hypertension
- Trial name
- NCT00487123
- Testing
- Valsartan+/- Hydrochlorothiazide
- Where
- Singapore
- Sponsor
- Novartis
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
Vascular Closure
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
- Trial name
- SEAL PM (NCT01858636)
- Testing
- Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
- Where
- 6 sites in Germany, Netherlands
- Volunteers
- 235 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
Femoral Arteriotomy Closure
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of…
- Trial name
- NCT02521948
- Testing
- MANTA Vascular Closure Device
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 50 people
- Sponsor
- Essential Medical, Inc.
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.
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
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.