Clinical trials: Fistula Stenosis
Renal Insufficiency
DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis
The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to…
- Trial name
- DEB-after-CB (NCT02578784)
- Testing
- Angioplasty with drug-coated balloon, Angioplasty with plain old balloon
- Where
- Switzerland
- Volunteers
- 40 people
- Sponsor
- Cantonal Hospital of St. Gallen
Stenosis
RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas. 2.
- Trial name
- NCT00543348
- Testing
- CUTTING BALLOON ANGIOPLASTY, Balloon angioplasty
- Where
- United States
- Sponsor
- Henry Ford Health System
Arteriovenous Fistula
Post Approval Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to collect post-market, real-world safety and effectiveness data of the COVERA Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the arteriovenous…
- Trial name
- NCT04261686
- Testing
- Covera Vascular Covered Stent
- Where
- 11 sites in United States
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
PRF, Hypospadias
A Multicenter Randomized Controlled Trial Comparing Platelet-Rich Fibrin and Ventral Dartos Flap as Intermediate Layers in Tabularized Incised Plate (TIP) Urethroplasty for Distal Hypospadias With Mild Penile Curvature
Distal hypospadias is the most common form of hypospadias. The Tubularized Incised Plate (TIP) repair is the standard surgical technique for this condition; however, complications such as fistula formation and meatal stenosis…
- Conditions
- PRF, Hypospadias, Distal Hypospadias, Hypospadias Repair
- Trial name
- PRF (NCT07045545)
- Testing
- - Group A: Platelet-rich fibrin membrane prepared intraoperatively and applied over neourethra, Group B: Ventral dartos flap rotated over neourethra
- Where
- Uzbekistan
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- National Children's Medical Center, Uzbekistan
Arterio-venous Fistula, Dialysis Access Malfunction
Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis.
- Conditions
- Arterio-venous Fistula, Dialysis Access Malfunction, Hemodialysis Access Failure, Arteriovenous Graft Stenosis
- Trial name
- SEMPER FI (NCT04381754)
- Testing
- Passeo-18 Lux
- Where
- Singapore
- Volunteers
- 100 people
- Sponsor
- Singapore General Hospital
Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion
IN.PACT™ AV Access IDE Study
To evaluate the safety and efficacy of the IN.PACT™ AV Access Drug Coated Balloon (DCB) compared to percutaneous transluminal angioplasty (PTA) for treatment of subjects presenting with de novo or non-stented restenotic…
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Arteriovenous Fistula, Fistula
- Trial name
- NCT03041467
- Testing
- IN.PACT AV DCB, Standard Balloon Angioplasty
- Where
- 29 sites in United States, Japan and 1 more
- Volunteers
- 330 people
- Sponsor
- Medtronic Endovascular
Neointimal Hyperplasia, Dialysis Access Malfunction
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD).
- Trial name
- PREDATOR (NCT05360394)
- Testing
- Paclitaxel Coated Balloon, Paclitaxel Coated Balloon and Stent Graft
- Where
- 2 sites in Australia, Singapore
- Volunteers
- 80 people
- Sponsor
- Singapore General Hospital
Peripheral Artery Disease, Arteriovenous Fistula Stenosis
FLEX Arteriovenous Access Registry
Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.
- Conditions
- Peripheral Artery Disease, Arteriovenous Fistula Stenosis, Arteriovenous Graft Stenosis
- Trial name
- NCT04070365
- Testing
- FLEX Vessel Prep System followed by angioplasty
- Where
- 10 sites in United States
- Volunteers
- 114 people
- Sponsor
- VentureMed Group Inc.
Venous Stenosis, Venous Occlusion
The Merit WRAPSODY AV Access Efficacy Study (WAVE)
The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit
- Trial name
- WAVE (NCT04540302)
- Testing
- Merit WRAPSODY Endovascular Stent Graft, PTA
- Where
- 43 sites in United States, Brazil and 2 more
- Volunteers
- 357 people
- Sponsor
- Merit Medical Systems, Inc.
Hemodyalysis
AVF-MONITOR POC Proof-of-concept Study
This is a proof-of-concept single-centre prospective longitudinal interventional study performed in AVF patients under HD treatment at the Nephrology and Dialysis Department of the ASST-Papa Giovanni XXIII (Bergamo, Italy)…
- Trial name
- AVFMONITOR POC (NCT07318025)
- Testing
- AVF MONITOR
- Where
- Italy
- Volunteers
- 6 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Uremia, Arteriovenous Fistula
Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial
The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in…
- Conditions
- Uremia, Arteriovenous Fistula, Stenosis
- Trial name
- SAVEIT (NCT02266238)
- Testing
- DSA guided percutaneous balloon dilatation, Ultrasound guided percutaneous balloon dilatation, Surgical reconstruction
- Where
- China
- Volunteers
- 450 people
- Sponsor
- Shanghai Changzheng Hospital
Esophageal Fistula, Esophageal Neoplasms
Removal of the Evolution® Esophageal Stent - Fully Covered
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
- Conditions
- Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis
- Trial name
- CLARITY (NCT01900691)
- Testing
- Evolution® Esophageal Stent - Fully Covered
- Where
- 11 sites in United States
- Volunteers
- 130 people
- Sponsor
- Cook Group Incorporated
Crohn's Disease
Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease
The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as…
- Trial name
- EEN-CD (NCT07504510)
- Testing
- Exclusive Enteral Nutrition
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
Arteriovenous Fistula Stenosis
AcoArt III / Arterio-venous Fistula in China
This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.
- Trial name
- NCT03366727
- Testing
- drug-coated balloon catheter （Orchid, Acotec）, plain balloon catheter (Admiral, medtronic)
- Where
- 13 sites in China
- Volunteers
- 244 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Arterial Disease, Fistula
A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in…
- Trial name
- NCT02962141
- Testing
- Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Balloon Dilatation Catheter
- Where
- 9 sites in China
- Volunteers
- 161 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)
Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)
Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease.
- Trial name
- B3AV (NCT02408822)
- Testing
- PTA Balloon dilatation catheter Advance® (Cook® Medical), Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®
- Where
- 3 sites in France
- Volunteers
- 52 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Arterio-venous Fistula
Far Infrared Therapy on Arteriovenous Fistulas in Hemodialysis Patients
The number of hemodialysis patients in the world are increasing. In order to receive a sufficient dialysis, the patients needs a well functioning and stable vascular access - preferably an arteriovenous fistula (AVF).
- Trial name
- NCT04011072
- Testing
- Far infrared radiation
- Where
- 9 sites in Denmark
- Volunteers
- 206 people
- Sponsor
- Herlev and Gentofte Hospital
Arteriovenous Fistula Stenosis, Arteriovenous Fistula
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
- Conditions
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula, Vascular Access
- Trial name
- NCT06639451
- Testing
- RANGER™ Paclitaxel Coated Balloon Catheter
- Where
- 8 sites in Japan
- Volunteers
- 186 people
- Sponsor
- Boston Scientific Corporation
Dialysis Access Malfunction, End Stage Renal Failure on Dialysis
MAgicTouch™ Intervention Leap for Dialysis Access (MATILDA) Trial
For patients with End Stage Renal Failure (ESRF), the surgical creation of an Autogenous Arteriovenous Fistula (AVF) or Autogenous Arteriovenous Graft (AVG) is the recognised standard for providing vascular access.
- Conditions
- Dialysis Access Malfunction, End Stage Renal Failure on Dialysis, End Stage Renal Disease, Fistulas Arteriovenous
- Trial name
- MATILDA (NCT04698512)
- Testing
- AVFistuloplasty with Sirolimus coated balloon
- Where
- Singapore
- Volunteers
- 35 people
- Sponsor
- Singapore General Hospital
Cerebrovascular Disease, Ischemic Stroke
Florida Cerebrovascular Disease Biorepository and Genomics Center
The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by…
- Conditions
- Cerebrovascular Disease, Ischemic Stroke, Transient Ischemic Attack, Intracerebral Hemorrhage
- Trial name
- NCT05491980
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Mayo Clinic