Clinical trials: Percutaneous Closure
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
Peripheral Vascular Disease, Cardiovascular Disease
RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System
To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.
- Trial name
- NCT00736086
- Testing
- Vessel Closure (StarClose™)
- Where
- 11 sites in United States
- Volunteers
- 165 people
- Sponsor
- Abbott Medical Devices
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
Stroke, PFO - Patent Foramen Ovale
The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
- Trial name
- PROOF (NCT04029233)
- Testing
- Occlutech PFO Occluder
- Where
- 17 sites in Canada, France and 2 more
- Volunteers
- 582 people
- Sponsor
- Occlutech International AB
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 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
Peripheral Arterial Disease, Arterial Puncture
The Safety and Efficacy of the Suture-Mediated Closure System
This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the…
- Trial name
- NCT05841836
- Testing
- the Suture-Mediated Closure System, Perclose ProGlide Suture-Mediated Closure System
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
Surgical Wound
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.
- Trial name
- Closer (NCT02136004)
- Testing
- Closer VSS
- Where
- 12 sites in United States
- Volunteers
- 220 people
- Sponsor
- Rex Medical
Vascular Closure, Femoral Arteriotomy Closure
The Ladera Suture-Mediated Large Bore Closure Study
This study evaluates the safety and performance of the Ladera Medical suture-mediated large bore closure (LBC) system in gaining post procedure hemostasis in subjects undergoing interventional catheterization procedures using a…
- Trial name
- FASTEN (NCT06851481)
- Testing
- Ladera LBC System
- Where
- 6 sites in Australia, Belgium and 1 more
- Volunteers
- 55 people
- Sponsor
- Ladera Medical
Anal Fistulas, Rectal Fistulas
A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
The study is designed as a prospective, non-randomized clinical trial comparing safety and effectiveness of the CuraSeal PICS-AF device to historical data from commercially available devices for the treatment of anorectal…
- Trial name
- NCT02456324
- Testing
- PICS-AF Device, Historical Controls Treated with Commercially Available Fistula Plugs
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- Curaseal Inc.
Migraine, Migraine With Aura
PRIMA PFO Migraine Trial
The purpose of this study is to evaluate migraine headache frequency in subjects who have migraine with aura and a patent foramen ovale (PFO, a slit-like opening between the right and left upper chambers (atria) of the heart…
- Conditions
- Migraine, Migraine With Aura, Patent Foramen Ovale, PFO
- Trial name
- PRIMA (NCT00505570)
- Testing
- AMPLATZER® PFO Occluder Device
- Where
- 17 sites in Canada, Germany and 2 more
- Volunteers
- 107 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.
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
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
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.
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.
Left Atrial Appendage, Non-Valvular Atrial Fibrillation
Canadian Left Atrial Appendage Closure Study
The purpose of the study is to demonstrate the safety and the rate of closure of the Ultrasept Left Atrial Appendage (LAA) Closure System for the percutaneous occlusion of the left atrial appendage in patients with non-valvular…
- Trial name
- CLASS (NCT03133806)
- Testing
- Ultrasept LAA Closure System
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Cardia Inc.
Percutaneous Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER V Study
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites.
- Trial name
- NCT04799769
- Testing
- Percutaneous arterial closure device
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 90 people
- Sponsor
- Vivasure Medical Limited
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.