Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

Status Completed

Clinical Trial Summary

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

Clinical Trial Description

In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01174472
Study type	Interventional
Source	University of Patras
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	March 2010
Completion date	January 2012

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05031013` - Trace Elements Concentration in Dialysis
Not yet recruiting	`NCT03090828` - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease	N/A
Completed	`NCT01685372` - Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults	Phase 2
Active, not recruiting	`NCT01394770` - Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients	Phase 4
Completed	`NCT00506441` - A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia	Phase 3
Completed	`NCT00537979` - Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis	Phase 4
Completed	`NCT05415969` - CKD-aP Among Adults on Dialysis in Switzerland
Recruiting	`NCT04024007` - Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
Completed	`NCT03772171` - Estimate for Dietary Intakes and Hemodialysis Patients
Recruiting	`NCT02586402` - Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis	Phase 2
Active, not recruiting	`NCT01693263` - Outcome of BCF Access in Hemodialysis Patients
Completed	`NCT01421771` - Blood Pressure in Dialysis Patients	N/A
Active, not recruiting	`NCT01065389` - Resistance Training in Intradialysis Patients	Phase 2
Completed	`NCT00544492` - Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients	Phase 4
Completed	`NCT03910426` - Prognostic Determinants of Survival and Quality of Life in Prevalent End-stage Kidney Disease Patients
Completed	`NCT04667741` - Post-dialysis Recovery Time and Affecting Factors Between Turkey and Portugal
Completed	`NCT04565522` - Transmission of COVID-19 Virus Among Patients and Staff in Dialysis Centers
Completed	`NCT04655989` - A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System	N/A
Completed	`NCT05125848` - Clinical Evaluation of the CM-1500 During Hemodialysis	N/A
Completed	`NCT04633915` - Antibody Response in Hemodialysis and Non-dialysis Patients Diagnosed With COVID-19.