Clinical trials: Vascular Closure Device
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.
Patent Foramen Ovale, Stroke
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder…
- Conditions
- Patent Foramen Ovale, Stroke, Transient Ischemic Attack (TIA)
- Trial name
- SAFE-PFO (NCT07380490)
- Testing
- PFO Closure procedure
- Where
- Germany
- Volunteers
- 1,260 people
- Sponsor
- Giuseppe Tarantini
Atrial Fibrillation, Bleeding
HEAL-LAA Clinical Trial
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation, Bleeding, Stroke
- Trial name
- HEAL-LAA (NCT05809596)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 45 sites in United States
- Volunteers
- 949 people
- Sponsor
- Boston Scientific Corporation
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 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
Atrial Fibrillation, Stroke Prevention
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
- Trial name
- NCT06580275
- Testing
- CLAAS
- Where
- 4 sites in Czechia, Denmark and 1 more
- Volunteers
- 67 people
- Sponsor
- Conformal 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.
Percutaneous CFA Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device FIV
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2.
- Trial name
- Frontier-IV (NCT03423602)
- Testing
- PerQseal®
- Where
- 11 sites in Germany, Ireland
- Volunteers
- 75 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
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.
Leg Ulcers, Diabetic Foot Ulcer
Vacuum Compression Therapy for Chronic Lower Limb Ulcers
The goal of this clinical trial is to learn if vacuum compression therapy added to standard care improves wound healing in adults with chronic lower limb ulcers.
- Conditions
- Leg Ulcers, Diabetic Foot Ulcer, Varicose Ulcers, Skin Ulcer
- Trial name
- NCT07737184
- Testing
- Vacuum Compression Therapy (VCT), Standardized Wound Care
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- BTL Industries Ltd.
Endovascular
Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular…
- Trial name
- PANDA (NCT03923387)
- Testing
- MynxGrip, Manual compression
- Where
- China
- Volunteers
- 306 people
- Sponsor
- Cordis US Corp.
Atrial Fibrillation, Stroke
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
- Trial name
- PREVAIL (NCT01182441)
- Testing
- WATCHMAN Device, Warfarin
- Where
- 41 sites in United States
- Volunteers
- 407 people
- Sponsor
- Boston Scientific Corporation
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
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
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 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
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
18 to 24 F Percutaneous Femoral 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-III (NCT02788448)
- Testing
- VIVASURE CLOSURE DEVICE
- Where
- 3 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Vivasure Medical Limited
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.