Drug-coated Balloon Versus Conventional Balloon Angioplasty in Hemodialysis Graft

NCT02706444 | Unknown Phase 4 DMC

• 1 other identifier: KUH1140101
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Primary patency (Fistulogram can be used for measurement of stenosis)

  6 months

Study Arms (2)

Conventional Balloon Angioplasty

ACTIVE COMPARATOR

Conventional balloon angioplasty. After fistulogram, full expansion of conventional 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

Device: Conventional Balloon angioplasty

Drug-Coated Balloon Angioplasty

ACTIVE COMPARATOR

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

Device: Drug-coated Balloon angioplasty

Interventions

Conventional Balloon angioplasty DEVICE

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)

Conventional Balloon Angioplasty

Drug-coated Balloon angioplasty DEVICE

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)

Drug-Coated Balloon Angioplasty

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of more than 19
• Hemodialysis patients with AVG in their arms: Graft should be implanted 30 days ago before enrollment
• Vascular access actively used for hemodialysis: At least one hemodialysis successful session before enrollment.
• Clinical signs of access dysfunction: decreased thrill, increased pulsatility, development collateral veins, limb swelling, difficulty in cannulation, prolonged bleeding after hemodialysis, high venous pressure or decreased hemodialysis flow rate during hemodialysis.
• \> 50% venous anastomotic stenosis of AVG, confirmed by fistulogram (angiography).
• ≦ 4cm from venous anastomosis site in lesion length
• Reference diameter \< 7mm of non-stenotic vessel or graft adjacent to venous stenosis.
• Full expansion of conventional balloon during primary balloon angioplasty, confirmed by fluoroscopy.

You may not qualify if:

• Patients unable to provide informed consent
• Patient unable to abide with study follow-up protocol.
• Patient participating in other relevant or conflicting studies
• Bare metal stent or stent-graft placed previously
• Hemodynamically significant stenosis of the central venous system
• ≧50% stenosis in arterial anastomotic site or venous outflow tract, non including venous anastomosis site
• Stenosis with a corresponding thrombosis treated within 7 days before enrollment.
• Limited life expectancy less than 6 months
• Sepsis or active infection.
• Recent arm thrombophlebitis (\< 6months).
• Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
• Pregnancy or Nursing state

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: March 11, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2018
• Last Updated: March 11, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share