Clinical trials: Vascular Closure Devices
Arterial Occlusion, Cardiovascular Diseases
Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- NCT05468957
- Testing
- Perclose, Statseal
- Where
- 2 sites in United States
- Sponsor
- University of California, Los Angeles
Cardioembolic Stroke, Atrial Fibrillation
Left Atrial Appendage Closure With SentreHeart Lariat® Device
The study cohort will consist of up to 50 patients who are candidates for Left Atrial Appendage (LAA) closure in whom oral anticoagulation is contraindicated.
- Trial name
- Lariat (NCT02681042)
- Testing
- Left atrial appendage closure, SentreHeart Lariat®
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Baylor Research Institute
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, Hemostasis
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC).
- Trial name
- NCT06078735
- Testing
- Vascular closure with LockeT device
- Where
- 6 sites in United States
- Volunteers
- 110 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
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
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
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
Hemostasis,Surgical
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.
- Trial name
- NCT00507013
- Testing
- QuickClose device
- Where
- Israel
- Volunteers
- 8 people
- Sponsor
- CardioDex
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
Aortic Valve Stenosis, Postoperative Complications
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral…
- Conditions
- Aortic Valve Stenosis, Postoperative Complications, Vascular System Injuries, Hemorrhage
- Trial name
- SEAL-TAVI (NCT07743697)
- Testing
- Single Suture-Based Vascular Closure Device, Extravascular Collagen Plug-Based Closure Device
- Where
- Switzerland
- Volunteers
- 705 people
- Sponsor
- University Hospital, Basel, Switzerland
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 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
Atrial Fibrillation, Stroke
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
- Trial name
- PREVAIL (NCT01182441)
- Testing
- WATCHMAN Device, Warfarin
- Where
- 41 sites in United States
- Volunteers
- 407 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
- Trial name
- ISAR-CLOSURE (NCT01389375)
- Testing
- FemoSeal®, ExoSeal®, Manual compression
- Where
- 2 sites in Germany
- Volunteers
- 4,524 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Atrial Fibrillation, Bleeding
HEAL-LAA Clinical Trial
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation, Bleeding, Stroke
- Trial name
- HEAL-LAA (NCT05809596)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 45 sites in United States
- Volunteers
- 949 people
- Sponsor
- Boston Scientific Corporation
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
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
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
Femoral Arteriotomy Closure
Clinical Study to Evaluate the Safety and Performance of MANTA Vascular Closure Device
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of…
- Trial name
- NCT02521948
- Testing
- MANTA Vascular Closure Device
- Where
- 3 sites in Italy, Netherlands
- Volunteers
- 50 people
- Sponsor
- Essential Medical, Inc.
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