Clinical trials: Vascular Closure Devices
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
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.
Atrial Fibrillation, Stroke
Peri-device Leakage Closure After LAAO
The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding, Leakage of Cardiac Device
- Trial name
- NCT04590898
- Testing
- Peri-device leakage closure after left atrial appendage occlusion
- Where
- 16 sites in United States, Denmark and 5 more
- Volunteers
- 85 people
- Sponsor
- Cardiovascular Center Frankfurt
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
Peripheral Arterial Disease
The AbsorbaSeal Vascular Closure Device Trial
This study investigates the efficacy and safety of the AbsorbaSeal 6Fr Vascular Closure device (VCD) for the closure of access site of patients requiring percutaneous diagnostic or interventional procedures.
- Trial name
- NCT03730571
- Testing
- AbsorbaSeal 6Fr Vascular Closure Device
- Where
- 3 sites in Belgium
- Volunteers
- 9 people
- Sponsor
- ID3 Medical
Coronary Angioplasty, Coronary Artery Disease
Arterial Closure vs Direct Compression for Hemostasis After PCI - The ACDC Trial
Hemostasis at the arterial puncture site after percutaneous coronary interventions is achieved by either placement of a puncture closure device or by delaying sheath removal for hours to allow normalization of heparin induced…
- Trial name
- NCT00264264
- Testing
- Closure Device, Direct Compression
- Where
- Canada
- Volunteers
- 572 people
- Sponsor
- Unity Health Toronto
Vascular Complications
Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery
The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.
- Trial name
- BEST-CFA (NCT05220540)
- Where
- 3 sites in Hungary
- Volunteers
- 24 people
- Sponsor
- Semmelweis University Heart and Vascular Center
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
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
Plug Arterial Closure System (PACS, 7F)
The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard…
- Trial name
- PACS 7F (NCT00533156)
- Testing
- Vascular access site closure (7F Ensure)
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Cordis US Corp.
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
Comparison of Different Vascular Closure Device in TAVI
Femoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging.
- Trial name
- NCT05491070
- Testing
- Vascular closure device (Angio-Seal, Progilde)
- Where
- Taiwan
- Volunteers
- 260 people
- Sponsor
- National Taiwan University Hospital
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
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
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.