Clinical trials: Vascular Closure
Coronary Artery Disease
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention…
- Trial name
- ARISTOCRAT (NCT02061696)
- Testing
- Vascular Access Device, Standard Manual Compression
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Frank Saltiel
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Vascular Closure
Patient Comfort With Vascular Closure
The purpose of this research study is to collect information on the amount of discomfort patients experience with one of two different vascular blood vessel closure devices, the MynxM5 Vascular Closure Device and the Angio-Seal…
- Trial name
- NCT00998023
- Testing
- Mynx Vascular Closure Device, AngioSeal Vascular Closure Device
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- University of Florida
Vascular Closure
Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
- Trial name
- NCT03756558
- Testing
- Cross-Seal System
- Where
- 20 sites in United States
- Volunteers
- 147 people
- Sponsor
- Terumo Medical Corporation
Diabetic Foot Ulcer
Celliant Socks to Increase Tissue Oxygenation and Complete Wound Closure in Diabetic Foot Wounds
This study is a prospective, multicenter, double-blind, 1:1 randomized clinical trial. The purpose of this study is to demonstrate that the use of Celliant Socks increases tissue oxygenation (via oxygen saturation, StO2) and…
- Trial name
- NCT04709419
- Testing
- Celliant Diabetic Medical Socks
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Texas Southwestern Medical Center
Surgical Wound
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites.
- Trial name
- RESPECT (NCT01297322)
- Testing
- Manual compression, Cardiva VASCADE™ Vascular Closure System
- Where
- 21 sites in United States, Australia
- Volunteers
- 420 people
- Sponsor
- Cardiva Medical, Inc.
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
Stroke
WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System.
- Trial name
- WAVECREST2 (NCT03302494)
- Testing
- Coherex WaveCrest® Left Atrial Appendage Occlusion System, Watchman® LAA Closure Device
- Where
- 25 sites in United States, Australia
- Volunteers
- 248 people
- Sponsor
- Coherex Medical
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.
Surgical Wound
AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS)
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites at the completion of catheter-based procedures…
- Trial name
- NCT03573206
- Testing
- Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Cardiva Medical, Inc.
Atrial Fibrillation
VAscular Closure for Cardiac Ablation Registry (VACCAR)
The objective of this registry is to find out if there is a difference in patient satisfaction and rate of vascular and bleeding complications with use of Perclose Proglide system or F08S for venous closure post atrial…
- Trial name
- VACCAR (NCT03546439)
- Where
- United States
- Volunteers
- 434 people
- Sponsor
- Saint Luke's Health System
Acute Coronary Syndrome
AngioSeal Versus Radial Approach in Acute Coronary Syndrome
Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence…
- Trial name
- ARISE (NCT01653587)
- Testing
- Percutaneous coronary intervention
- Where
- Brazil
- Volunteers
- 240 people
- Sponsor
- Irmandade Santa Casa Misericórdia Marília
Surgical Wound
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA)…
- Trial name
- NCT03193021
- Testing
- Cardiva Mid-Bore VVCS, Manual compression
- Where
- 13 sites in United States
- Volunteers
- 204 people
- Sponsor
- Cardiva Medical, Inc.
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
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
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
Endovascular
Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular…
- Trial name
- PANDA (NCT03923387)
- Testing
- MynxGrip, Manual compression
- Where
- China
- Volunteers
- 306 people
- Sponsor
- Cordis US Corp.
Left Atrial Appendage Closure, WATCHMAN Device Implantation
The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before…
- Trial name
- NCT03040622
- Testing
- WATCHMAN Left Atrial Appendage Closure
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Inova Health Care Services
Non-valvular Atrial Fibrillation
WAVECREST Post Market Clinical Follow-Up (PMCF) Study
The WAVECREST PMCF Study is a prospective, non-randomized, multicenter study to confirm safety and performance of the Coherex WaveCrest Left Atrial Appendage (LAA) Occlusion System in the current medical practice setting in…
- Trial name
- NCT03204695
- Testing
- Percutaneous LAA Closure, Anticoagulation or Clopidogrel
- Where
- Belgium
- Volunteers
- 27 people
- Sponsor
- Coherex Medical
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral…
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis, Peripheral Arteriosclerosis
- Trial name
- NCT00345631
- Testing
- Manual Compression, Vascular Closure Device
- Where
- 17 sites in United States
- Volunteers
- 488 people
- Sponsor
- Cordis US Corp.