Clinical trials: Vascular Access Devices
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.
Stenoses
Pivotal Study for the FLAIR Endovascular Stent Graft
This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.
- Trial name
- NCT00678249
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 227 people
- Sponsor
- C. R. Bard
End-Stage Renal Disease Requiring Haemodialysis, Hemodialysis Access Failure (Disorder)
BONE ANCHORED PORT for Hemodialysis Treatment
A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a…
- Trial name
- BAP (NCT02069860)
- Testing
- Bone Anchored Port System (BAP)
- Where
- Switzerland
- Volunteers
- 6 people
- Sponsor
- Cendres+Métaux
Thrombosis, Venous Thrombosis
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Catheters
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of study drug to an occluded central…
- Conditions
- Thrombosis, Venous Thrombosis, Catheter Occlusion
- Trial name
- NCT00322270
- Testing
- Alfimeprase
- Where
- 18 sites in United States
- Sponsor
- ARCA Biopharma, Inc.
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.
Vascular Closure Devices
xDot Access Management System Pivotal Study
The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure.
- Trial name
- NCT07719244
- Testing
- xDot Access Management System (AMS)
- Volunteers
- 266 people
- Sponsor
- xDot Medical, Inc
Peripheral Vascular Disease, Coronary Artery Disease
Angio-Seal Evolution Device Registry
Collect data on the use of the Angio-Seal Evolution Device in diagnostic and interventional patient populations.
- Conditions
- Peripheral Vascular Disease, Coronary Artery Disease, Peripheral Artery Disease, Arterial Occlusive Disease
- Trial name
- NCT00817349
- Where
- 10 sites in United States
- Volunteers
- 1,004 people
- Sponsor
- Abbott Medical Devices
Vascular Closure, Endovascular Procedure
Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study
The study aims to further demonstrate the safety and effectiveness of the FemoSeal™ VCS in achieving hemostasis following percutaneous endovascular procedures performed via the common femoral artery (CFA) access site.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- FEMOSEAL CLOSE (NCT05027698)
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Vascular Access Complication
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01943474
- Testing
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the…
- Trial name
- NCT02119832
- Testing
- Endovasccular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
Dialysis; Complications, Vascular Access Complication
Access Cannulation Trial II
This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating…
- Trial name
- ACT II (NCT05490225)
- Testing
- VenaSure
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- Voyager Biomedical
Vascular Access
A Comprehensive Look at Vascular Access
The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.
- Trial name
- NCT01638065
- Where
- 2 sites in United States
- Volunteers
- 196 people
- Sponsor
- Christie Medical Holdings, Inc.
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
Thrombosis, Venous Thrombosis
Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters
The purpose of the study is to compare the safety and effectiveness of alfimeprase to a placebo in restoring function of occluded central catheters.
- Trial name
- NCT00346424
- Testing
- Alfimeprase
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- ARCA Biopharma, Inc.
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
Vascular Access, End Stage Renal Disease
A Multi Center, Study to Evaluate the Safety and Efficacy of the VasQ External Support Device for Arteriovenous Fistulas
This study is a prospective, multi center, randomized, controlled study of the VasQ in arteriovenous fistulas. The VasQ constraints and directs the geometrical parameters of the fistula as well as the vascular diameter and…
- Trial name
- NCT02112669
- Testing
- VasQ
- Where
- 4 sites in Israel, United Kingdom
- Volunteers
- 60 people
- Sponsor
- Laminate Medical Technologies
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
Hemodialysis
HeRO Vascular Access Device Bacteremia Study
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients.
- Trial name
- NCT00889564
- Testing
- HeRO Vascular Access Device
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Merit Medical Systems, Inc.
End Stage Renal Disease
HeRO Vascular Access Device Post Market Procedural Survey Protocol
Post market observational survey of a vascular access device for access-challenged patients. Data collection efforts focused on patient medical and access history and implant procedure results.
- Trial name
- PPS (NCT00889291)
- Volunteers
- 77 people
- Sponsor
- Merit Medical Systems, Inc.