Clinical trials: Fistula Stenosis
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.
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
Fistulas Arteriovenous
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses.
- Trial name
- DissolveAVF (NCT04226599)
- Testing
- Dissolve AVF, Armada 35
- Where
- 10 sites in China
- Volunteers
- 220 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Arteriovenous Fistula Stenosis
Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
- Trial name
- NCT07452822
- Testing
- Human umbilical cord mesenchymal stem cells injection, saline solution
- Volunteers
- 54 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Peripheral Arterial Disease
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
- Trial name
- NCT06029569
- Testing
- Rapamycin drug balloon angioplasty, Paclitaxel drug balloon angioplasty
- Volunteers
- 256 people
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
Stenosis of Native Hemodialysis Arteriovenous Fistulas
ACOART AVF RENEW: A Post Market Clinical Study
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in…
- Trial name
- NCT06205576
- Testing
- DCB catheter
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Acotec Scientific Co., Ltd
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
- Trial name
- ULTRAVIOLETFIM (NCT07330817)
- Testing
- PTA balloon
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Cardionovum GmbH
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.
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
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.
Arteriovenous Fistula Stenosis
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous…
- Trial name
- SCDB (NCT06422845)
- Testing
- Dissolve AV Peripheral Scoring Drug-coated Balloon
- Where
- 33 sites in China
- Volunteers
- 328 people
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
Arteriovenous Fistula Stenosis
FLEX Vessel Prep Prior to Angioplasty in Native Arteriovenous Fistulae (AVF)
A prospective, multi-center, randomized observational post-market study evaluating the FLEX Vessel Prep device plus percutaneous angioplasty (PTA) vs PTA alone for the treatment of obstructive lesions in the native arteriovenous…
- Trial name
- NCT05034939
- Testing
- FLEX Vessel Prep System, Angioplasty
- Where
- 7 sites in United States
- Volunteers
- 75 people
- Sponsor
- VentureMed Group Inc.
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
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
Venous Stenosis, Venous Occlusion
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
The WRAP Study aims to expand and understand the safety and efficacy data on the WRAPSODY Endoprosthesis System in a real-world population.
- Trial name
- NCT05062291
- Testing
- Merit WRAPSODY Endovascular Stent Graft
- Where
- 35 sites in Australia, Brazil and 7 more
- Volunteers
- 500 people
- Sponsor
- Merit Medical Systems, Inc.
Esophageal Diseases
Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
The aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered).
- Trial name
- NCT05182255
- Testing
- Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
- Where
- 5 sites in Germany, Spain and 1 more
- Volunteers
- 127 people
- Sponsor
- Cook Research Incorporated
Arteriovenous Fistula
FLEX®-DCB Dialysis ACCESS Stenosis Study
This prospective, single arm, single-center study is designed to evaluate the performance of the FLEX Scoring Catheter®/POBA/DCB in A-V access circuits.
- Trial name
- AVAFLEX (NCT03566927)
- Testing
- FLEX Scoring Catheter with Lutonix DCB
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- VentureMed Group Inc.
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
Venous Stenosis, Venous Occlusion
WRAP North America
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population.
- Trial name
- NCT06807099
- Testing
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Where
- 16 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Merit Medical Systems, Inc.
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard