Clinical trials: Vascular Closure Devices
Stroke, Transient Ischemic Attack
International PFO Consortium
The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke).
- Trial name
- NCT00859885
- Testing
- Antithrombotic treatment, percutaneous device closure of PFO
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 1,500 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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.
Aortic Valve Stenosis
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI).
- Trial name
- CHOICE-CLOSURE (NCT04459208)
- Testing
- Manta, ProGlide
- Where
- Germany
- Volunteers
- 516 people
- Sponsor
- Helios Health Institute GmbH
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.
Aortic Valve Stenosis
Vascular Closure Device in Transcatheter Aortic Valve Replacement
Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a…
- Trial name
- NCT04392492
- Testing
- MANTA vascular closure device
- Where
- Sweden
- Volunteers
- 1,000 people
- Sponsor
- Karolinska University Hospital
Aortic Valve Stenosis
Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation
The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore…
- Trial name
- ACCESS-TAVI (NCT05503199)
- Testing
- Combination of one Perclose ProGlide or ProStyle (Abbott Vascular) and one Angio-Seal (Terumo)., Combination of two ProGlides or ProStyles (Abbott Vascular).
- Where
- Germany
- Volunteers
- 450 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Femoral Artery Injury, Aortic Valve Insufficiency
Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter…
- Trial name
- MANTA-MICS (NCT04802200)
- Testing
- Data collect
- Where
- France
- Volunteers
- 204 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Vascular Closure
Groin Complications Post Percutaneous Coronary Intervention Using Either Manual Compression or PERCLOSE Device
The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual…
- Trial name
- NCT00842179
- Where
- United States
- Volunteers
- 2,517 people
- Sponsor
- Clinyx, LLC
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.
Atrial Fibrillation, Left Atrial Appendage Closure
Left Atrial Appendage Closure With the LAmbre
The study was to retrospectively analyse the efficacy and safety of LAA closure using the LAmbre in our center from April 2014 to November 2015.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Stroke
- Trial name
- NCT03147391
- Testing
- LAA closure with LAmbre
- Volunteers
- 66 people
- Sponsor
- Shanghai 10th People's Hospital
Patent Foramen Ovale, PFO
The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical…
- Conditions
- Patent Foramen Ovale, PFO, Stroke, TIA
- Trial name
- CryptoCard (NCT01018355)
- Testing
- Percutaneous device closure of patent foramen ovale
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Hillerod Hospital, Denmark
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 Intervention Via Femoral Artery
Star-Close Versus Angio-Seal for Femoral Artery Hemostasis
This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).
- Trial name
- CLOSE (NCT00590356)
- Testing
- StarClose®, AngioSeal®
- Where
- South Korea
- Sponsor
- Seung-Jung Park