Clinical trials: Vascular Closure Device
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
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.
Vascular Closure
AMBULATE Same Day Discharge Registry
A multi-center, prospective, single-arm post market registry, designed to collect both performance and complication outcomes when same day discharge is enabled by the study device, in sealing multiple femoral venous access sites…
- Trial name
- NCT04203329
- Testing
- Femoral Venous Vascular Closure
- Where
- 15 sites in United States
- Volunteers
- 700 people
- Sponsor
- Cardiva Medical, Inc.
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
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
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
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
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.
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU
To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
- Trial name
- ECLIPSE (NCT00574691)
- Testing
- 7F Ensure Medical Vascular Closure Device
- Where
- Germany
- Volunteers
- 93 people
- Sponsor
- Cordis US Corp.
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
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
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral…
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis, Peripheral Arteriosclerosis
- Trial name
- NCT00345631
- Testing
- Manual Compression, Vascular Closure Device
- Where
- 17 sites in United States
- Volunteers
- 488 people
- Sponsor
- Cordis US Corp.
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
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
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.
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
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
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
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.
Large Hole Percutaneous Arterial Closure
Safety and Performance Study of Large Hole Vascular Closure Device - France
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 20 patients in 2 centres within France.
- Trial name
- FRONTIER V (NCT05323877)
- Testing
- Test Device (PerQseal+)
- Volunteers
- 20 people
- Sponsor
- Vivasure Medical Limited