Clinical Trials Logo
  1. Home
  2. Arteriovenous Fistula
  3. NCT02746159

Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae — AVR  

Arteriovenous Fistula Clinical Trial

Official title:
A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic AV Fistulae

Clinical Trial Summary

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

Clinical Trial Description

This post market registry is intended to demonstrate safety and assess the clinical use and outcomes of the Lutonix DCB in a heterogeneous patient population with dysfunctional native or synthetic AV fistulae in real world clinical practice. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02746159
Study type Observational [Patient Registry]
Source C. R. Bard
Contact
Status Completed
Phase
Start date June 7, 2016
Completion date March 9, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05302505 - Simulation-based Training for Nurses and Arteriovenous Fistula Puncture in Chronic Hemodialysis Patients N/A
Terminated NCT01642459 - The Outcomes of Arteriovenous Fistula Cannulated From Different Direction. N/A
Recruiting NCT04017806 - Investigating the Role of Luminal Pressure on Arteriovenous Fistula Maturation
Terminated NCT03668002 - Trial of Fistula Versus Graft in Elderly Patients N/A
Completed NCT06199609 - Changes in Cardiac Structure and Function After Establishment of Autologous Arteriovenous Fistula
Recruiting NCT04034433 - Exercise Program for Arteriovenous Fistula Maturation N/A
Active, not recruiting NCT04629118 - Intervention With Selution SLR™ Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial
Recruiting NCT02913365 - Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis N/A
Recruiting NCT05616104 - FLEX FIRST Registry Research Protocol
Recruiting NCT03886116 - Effect of Pre-operative Forearm Exercises on Arterial Venous Fistula Maturation and Blood Flow N/A
Completed NCT02513303 - Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes Phase 3
Completed NCT01863914 - Vascular Protective Effect of Rosuvastatin in Arteriovenous Fistula Phase 2
Recruiting NCT06001827 - SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study N/A
Recruiting NCT04543539 - IN.PACT™ AV Access Post-Approval Study (PAS002)
Completed NCT05326321 - Effect of Virtual Reality Glasses in The Arteriovenous Fistule Cannulation Processon Paın and Patient Satisfaction N/A
Recruiting NCT03741985 - Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients With Hemodialysis N/A
Terminated NCT03566927 - FLEX®-DCB Dialysis ACCESS Stenosis Study N/A
Not yet recruiting NCT04393688 - Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV Fistula N/A
Recruiting NCT02447796 - Dexmedetomidine and Propofol As Sole Sedative Agent for Patients Undergoing Arteriovenous Fistula Surgery Phase 4
Terminated NCT01321866 - Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients N/A