Clinical trials: Vascular Closure Devices
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.
Patent Foramen Ovale, Cryptogenic Stroke
Encore PFO Closure Device - The PerFOrm Trial
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
- Trial name
- NCT05537753
- Testing
- Encore PFO closure device, FDA-approved PFO closure device
- Where
- 8 sites in United States
- Volunteers
- 500 people
- Sponsor
- Encore Medical Inc.
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
Femoral Arteriotomy Closure
X-Seal EU Post-Market Clinical Follow-Up Protocol
The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone…
- Trial name
- NCT02406612
- Testing
- X-Seal 6F Vascular Closure Device
- Where
- 2 sites in Germany
- Volunteers
- 47 people
- Sponsor
- Essential Medical, Inc.
Large Hole Percutaneous Venous Closure
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F)…
- Trial name
- ELITE-Venous (NCT06007339)
- Testing
- PerQseal ELITE
- Where
- Netherlands
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
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.
Femoral Arteriotomy Closure
MANTA Ultrasound Closure Study
Demonstrate the safety of MANTA Vascular Closure Device (VCD) ultrasound (U/S) guided closure in patients undergoing elective TAVR procedures with planned percutaneous femoral arterial access.
- Trial name
- MANTA ULTRA (NCT05142566)
- Testing
- MANTA Vascular Closure Device
- Where
- 6 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Essential Medical, Inc.
Vascular Diseases
EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)
A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after…
- Trial name
- ELITE (NCT03412942)
- Testing
- FISH SP
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Morris Innovative Incorporated
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- W.L.Gore & Associates
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.
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.
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.
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
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.
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