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Drug-coated Balloon Versus Conventional Balloon Angioplasty in Hemodialysis Graft

NCT02706444 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2016-03-11

No results posted yet for this study

Summary

To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous anastomotic stenosis of AVG in terms of patency.

Conditions

  • Vascular Graft Anastomotic Stenosis

Interventions

DEVICE

Conventional Balloon angioplasty

After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in \> 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty)

DEVICE

Drug-coated Balloon angioplasty

After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in \> 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty)

Sponsors & Collaborators

  • Konkuk University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-09-30
Completion
2018-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706444 on ClinicalTrials.gov