Clinical trials: Vascular Closure Devices
Atrial Fibrillation, Hemostasis
Vascular Closure With Novel External Compression Device: The LockeT Study
Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.
- Trial name
- NCT06199414
- Testing
- Venous Closure
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
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
Vascular Closure
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.
- Trial name
- SEAL PM (NCT01858636)
- Testing
- Angio-Seal VIP 6 French (6F) and 8 French (8F) devices
- Where
- 6 sites in Germany, Netherlands
- Volunteers
- 235 people
- Sponsor
- Abbott Medical Devices
Phoniatric Evaluation of Total Thyroidectomy
Phoniatric Evaluation and Comparison of Patients Who Underwent Sutureless Thyroidectomy With Vessel Closure Devices and Conventional Total Thyroidectomy With Suture
The purpose of this study is to compare effect of sutureless thyroidectomy with vessel closure devices and conventional thyroidectomy with suturing on voice quality with phoniatric evaluation.
- Trial name
- NCT01865006
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Istanbul University
Atrial Fibrillation
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot…
- Trial name
- Style-AF (NCT05563142)
- Testing
- deploying vascular closure device versus manual compression
- Where
- 3 sites in Germany
- Volunteers
- 125 people
- Sponsor
- University of Luebeck
Acute Coronary Syndromes, Stable Angina Pectoris
Angio-Seal® vs. Exo-Seal® for Closure of Arterial Puncture Sites
Background: Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions (PCI).
- Trial name
- NCT01669382
- Testing
- percutaneous coronary intervention
- Where
- 3 sites in Germany
- Volunteers
- 304 people
- Sponsor
- University Hospital Erlangen
Percutaneous Closure of Artery Access Sites
InSeal Vascular Closure Device Clinical Study Protocol
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
- VCD (NCT01896401)
- Testing
- InSeal's Vascular Closure Device
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- InSeal Medical Ltd.
Percutaneous Common Femoral Artery 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-II (NCT02241642)
- Testing
- VIVASURE CLOSURE DEVICE™
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 65 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
Coronary Angiography, Heart Catheterization
Accelerated Ambulation After Vascular Access Closure Device
The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early…
- Trial name
- NCT03142126
- Testing
- Early ambulation with Angioseal closure device
- Volunteers
- 28 people
- Sponsor
- Henry Ford Health System
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Myocardial Infarction, Complications; Device, Vascular
Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction.
- Conditions
- Myocardial Infarction, Complications; Device, Vascular, Injury of Radial Artery, Injury; Blood Vessel, Femoral, Artery
- Trial name
- ARISE-2 (NCT02831166)
- Testing
- Transradial primary percutaneous coronary intervention, Transfemoral primary percutaneous coronary intervention
- Where
- Brazil
- Volunteers
- 250 people
- Sponsor
- Irmandade Santa Casa Misericórdia Marília
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
Catheterization Via a Femoral Sheath ≤ 6Fr
CaveoVasc System - a New Femoral Vascular Access and Closure Device
The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.
- Trial name
- NCT02694549
- Testing
- CaveoVasc
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- CaveoMed GmbH
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Coronary Disease
Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.
- Trial name
- CLOSE-UP III (NCT02237430)
- Testing
- MynxGrip, Manual compression
- Where
- Denmark
- Volunteers
- 869 people
- Sponsor
- Aarhus University Hospital Skejby
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.
Aortic Valve Stenosis
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to suture-based VCDs in preventing vascular access site complications in patients undergoing transfemoral transcatheter aortic valve…
- Trial name
- MASH-TAVI (NCT03811119)
- Testing
- MANTA vascular closure device, Suture based vascular closure device
- Where
- Netherlands
- Volunteers
- 151 people
- Sponsor
- Erasmus Medical Center
Atrial Fibrillation
Venous Closure System After AF Ablation
This prospective, randomized, participant-blinded study will compare a suture-based venous closure system (Perclose ProGlide™) with a conventional figure-of-8 suture for femoral venous access-site closure in patients undergoing…
- Trial name
- NCT07814144
- Testing
- Perclose ProGlide™, Figure-of-8 suture
- Where
- South Korea
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Foramen Ovale, Patent, Stroke, Ischemic
NobleStitch EL STITCH Trial is a PFO Comparative Trial
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
- Trial name
- STITCH (NCT04339699)
- Testing
- NobleStitch™EL Suture Mediated Closure System, Amplatzer PFO Occluder
- Where
- 2 sites in United States, Italy
- Volunteers
- 640 people
- Sponsor
- Nobles Medical Technologies II Inc