Clinical trials: Access and Evaluation
Vascular Closure Device, Femoral Arteriotomy Closure
Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)
This study evaluates the safety and effectiveness of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional…
- Conditions
- Vascular Closure Device, Femoral Arteriotomy Closure, Femoral Access Site Closure
- Trial name
- NCT07862309
- Testing
- Novelrad Vascular Closure System (NVCS)
- Volunteers
- 65 people
- Sponsor
- Novelrad Ltd.
Hemodialysis, Clinical Assessment
Contactless Optical Monitoring of AV Access Using the PatenSee System in Outpatient Hemodialysis Patients
This is a prospective, non-interventional, single arm, international multicenter study in which up to 120 adult participants with kidney failure requiring regular hemodialysis through arteriovenous (AV) access (AV fistula or…
- Trial name
- NCT07194395
- Testing
- PatenSee System
- Where
- 2 sites in United States, Israel
- Volunteers
- 90 people
- Sponsor
- PatenSee Ltd.
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.
Rheumatoid Arthritis
A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients…
- Trial name
- NCT04047121
- Where
- United States
- Volunteers
- 1,349 people
- Sponsor
- Pfizer
Complication of Renal Dialysis, End Stage Renal Disease
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS (NCT02513303)
- Testing
- Sirolimus, AV Fistula Surgery, Sirolimus-eluting Collagen Implant (SeCI)
- Where
- 4 sites in United States
- Volunteers
- 269 people
- Sponsor
- Vascular Therapies, Inc.
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.
Type II Diabetes Mellitus
A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
A real-world, point-of-care, randomized, parallel group, open, 6-month clinical study to evaluate if the provision of a digital disease management tool improves glycaemic control in participants with type 2 diabetes mellitus…
- Trial name
- NCT02749435
- Testing
- Use of digital disease management tool in participants with T2DM
- Where
- 14 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- AstraZeneca
Aortic Valve Stenosis
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI)…
- Trial name
- NCT01721642
- Testing
- Apica Cardiovascular ASC Access, Stability and Closure Device
- Volunteers
- 31 people
- Sponsor
- Apica Cardiovascular Limited
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Interventions
Assessment of Clin. Capabilities of LIBERTY® Endovascular Robotic System's Performance & Safety in Periph. Vasc. Interv.
A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions.
- Trial name
- ACCESS-PVI (NCT06141694)
- Testing
- The LIBERTY® Robotic System
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Microbot Medical, INC
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
Type 2 Diabetes
Effects of Telemonitoring and Telemedicine Service for Type 2 Diabetes Care
A multi-center, randomized, parallel, interventional, open label trial to compare Hemoglobin A1C-lowering effect of conventional treatment and Smart Care Service in patients with type 2 diabetes.
- Trial name
- Smart-DM (NCT01345435)
- Testing
- Telemonitoring group, Telemonitoring & Telemedicine, SMBG
- Where
- 4 sites in South Korea
- Volunteers
- 417 people
- Sponsor
- CHANGHEE LEE
Intravenous Access According to Instructions For Use
Study Comparing the Handling of Two Peripheral IV Catheter Systems
A peripheral intravenous catheter is the most commonly used vascular access device in medicine. Primary objective is to compare insertion and handling of two peripheral intravenous catheters in clinical routine.
- Trial name
- NCT02213965
- Testing
- Peripheral IV catheter
- Where
- 2 sites in Germany
- Volunteers
- 2,340 people
- Sponsor
- B. Braun Melsungen AG
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
PR-0164 First in Human Clinical Trial of the PAVmed PortIO Intraosseous Infusion System
The PortIO is intended to provide non-emergent vascular access in chronic kidney disease (CKD) patients where preservation of venous anatomy is desired and iatrogenic damage to the veins should be avoided and/or patients with…
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Poor Vascular Access
- Trial name
- NCT06037265
- Testing
- PAVmed PortIO™ Intraosseous Infusion System
- Where
- 4 sites in Colombia
- Volunteers
- 15 people
- Sponsor
- PAVmed Inc.
Super-Refractory Status Epilepticus
An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus
This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these…
- Trial name
- NCT02433314
- Testing
- SAGE-547
- Sponsor
- Supernus Pharmaceuticals, Inc.
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation
Heart Failure
Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection
The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic…
- Trial name
- NCT04169815
- Testing
- Access Immunodiagnostic Products
- Where
- 15 sites in United States
- Volunteers
- 2,370 people
- Sponsor
- Beckman Coulter, Inc.
Atrial Fibrillation
Continued Access Protocol
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review.
- Trial name
- CAP-AF (NCT00889681)
- Testing
- Arctic Front Cardiac Cryoablation System
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates