Clinical trials: Vascular Closure
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
Diabetic Foot Ulcer
Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds
Singapore has one of the world's highest diabetes-related lower limb amputation rates in the world. Between 2008 - 2017, 4724/5306 (89.0%) of all major amputations and 6656/7227 (92.1%) of all toe/ray amputations performed in…
- Trial name
- NCT06832787
- Testing
- Negative Pressure Wound Therapy, Kerecis, Delayed primary closure with local flap
- Where
- 2 sites in Singapore
- Volunteers
- 75 people
- Sponsor
- Singapore General Hospital
Diabetic Foot Infection, Diabetic Foot
Multi-center Study to Assess Safety, Tolerability and Efficacy of Topical Pravibismane in Moderate DFI Patients
This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot…
- Trial name
- NCT05174806
- Testing
- Topical Pravibismane, Standard of Care
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Microbion Corporation
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
Stroke, Foramen Ovale, Patent
Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale
Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism.
- Trial name
- PFO-HUG (NCT01149447)
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- University Hospital, Geneva
Wound Closure, Brain Tumor Adult
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the…
- Conditions
- Wound Closure, Brain Tumor Adult, Spine, Neurovascular
- Trial name
- NCT07225101
- Testing
- STRATAFIX PDS and Monocryl suture
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- University of Michigan
Femoral Artery Puncture, Vascular Closure Device
Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture.
- Conditions
- Femoral Artery Puncture, Vascular Closure Device, Hemostasis
- Trial name
- NCT07279220
- Testing
- Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd., MynxGrip Vascular Closure Device Manufactured by Cordis US Corp
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
Coagulation, Therapeutic Uses
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose Design 9 System
The QuickClose Design 9 is a prospective, non randomized study, to evaluate the safety and efficacy of the QuickClose design 9 closure device.
- Conditions
- Coagulation, Therapeutic Uses, Pharmacologic Actions
- Trial name
- NCT01121510
- Testing
- closure device
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- CardioDex
Atrial Fibrillation, Stroke
Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation
The ASPIRIN LAAO trial is a prospective, multi-center, randomized, double blinded, placebo-controlled study aiming at investigating the safety of terminating the use of aspirin after left atrial appendage occlusion (LAAO).
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- ASPIRIN-LAAO (NCT03821883)
- Testing
- Aspirin Tablet
- Where
- China
- Volunteers
- 1,120 people
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
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
Atrial Fibrillation, Ischemic Stroke, Acute
Long-Term Outcomes of LAA Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry
This study is intended to assess the incidence and correlation to the development of peri-device leaks (PDLs), device related thrombosis (DRTs) and cerebral vascular accident (CVA)/transient ischemic attacks (TIAs) in association…
- Trial name
- NCT06075628
- Testing
- Left Atrial Appendage Occlusion
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair
GLYCAR Post Market Multicenter Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Trial name
- CIP002 (NCT05661981)
- Testing
- GLYCAR Pericardial Patch
- Where
- 4 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- GLYCAR SA (Pty) Ltd
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
Atrial Fibrillation, Left Atrial Appendage
Zenith LAA Occlusion System
Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- NCT05951101
- Testing
- Zenith LAA Occlusion System
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 10 people
- Sponsor
- AuriGen Medical Ltd
Patent Foramen Ovale, Ischemic Stroke
Patent Foramen Ovale Closure in Older Patients
Describe the baseline and procedural characteristics of older patients undergoing PFO closure due to cryptogenic embolism. Assess the long-term follow-up of this cohort, focusing on neurological events and their origin, major…
- Conditions
- Patent Foramen Ovale, Ischemic Stroke, Older People
- Trial name
- PFO-Elderly (NCT04780022)
- Testing
- Clinical events at last follow-up
- Where
- Canada
- Volunteers
- 350 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Wounds, Compartment Syndromes
Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes
The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.
- Trial name
- NCT00121537
- Testing
- Wound Care -Wound Vacuum Assisted Closure (VAC), Wound Care - Wet to Dry Dressing Changes
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Venous Insufficiency
RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study
The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).
- Trial name
- TRIPLE (NCT01079598)
- Testing
- RF Ablation (ClosureRFS Stylet)
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Medtronic Endovascular
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
Atrial Fibrillation, Coronary Artery Disease
Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease
Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus aspirin or dabigatran plus clopidogrel after…
- Trial name
- NCT02606552
- Testing
- Dabigatrain plus aspirin, Dabigatrain plus clopidogrel, Amplazter Cardiac Plug (ACP)
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Yonsei University