Clinical trials: Hemodialysis Access Failure
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
Renal Failure, End Stage Renal Disease
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Trial name
- NCT02644941
- Testing
- Human Acellular Vessel (HAV), ePTFE graft
- Where
- 38 sites in United States, Germany and 4 more
- Volunteers
- 355 people
- Sponsor
- Humacyte, Inc.
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.
End Stage Renal Failure, Hemodialysis Access Failure
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and…
- Conditions
- End Stage Renal Failure, Hemodialysis Access Failure, Arterio-venous Fistula
- Trial name
- NCT04376567
- Testing
- One stage approach
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Tze-Woei Tan
Hemodialysis Access Failure
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
- Trial name
- NCT03734679
- Testing
- SurVeil Drug Coated Balloon
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 12 people
- Sponsor
- SurModics, Inc.
Vascular Diseases, Peripheral Arterial Disease
Post-market, Prospective Evaluation of PHOTO-oxidized Bovine Pericardium in Vascular Surgery
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
- Conditions
- Vascular Diseases, Peripheral Arterial Disease, Hemodialysis Access Failure (Disorder), Carotid Artery Diseases
- Trial name
- PHOTO-V (NCT03669042)
- Testing
- PhotoFix
- Where
- 9 sites in United States
- Volunteers
- 94 people
- Sponsor
- Artivion Inc.
Kidney Failure, Chronic, Hemodialysis Complication
The Pristine Post-Market Study
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
- Conditions
- Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure
- Trial name
- NCT05228132
- Testing
- Pristine™ Long-Term Hemodialysis Catheter
- Where
- 6 sites in United States
- Volunteers
- 142 people
- Sponsor
- C. R. Bard
Renal Failure, End Stage Renal Disease
Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis
This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).
- Conditions
- Renal Failure, End Stage Renal Disease, Vascular Access, Hemodialysis
- Trial name
- NCT04135417
- Testing
- HAV
- Where
- 2 sites in Poland
- Volunteers
- 30 people
- Sponsor
- Humacyte, Inc.