Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses

NCT01544907 | Completed DMC

• 1 other identifier: DEBAPTA
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Conditions

Stenosis of Arteriovenous Dialysis Fistula; Arteriovenous Graft Stenosis

Keywords

Drug Eluting Balloon; Arteriovenous fistula or graft stenosis

Outcome Measures

Primary Outcomes (1)

• Late luminal loss

  Late luminal loss is defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram.

  6 months

Secondary Outcomes (7)

• Restenosis rate

  6 months

• Primary patency

  6 months

• Primary assisted patency

  6 months

• Secondary patency

  6 months

• Anatomic success

  Immediate post procedure

Study Arms (2)

Conventional PTA only

ACTIVE COMPARATOR

Treatment Arm 1- Conventional PTA only The conventional balloon is used and the diameter of the balloon should be the same or oversized by 1mm the diameter of the reference vessel. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 2 minutes. At the end of the first angioplasty, an AVFistulogram/AVGraftogram will be obtained to document results. If there is residual stenosis of \>30%, a repeat angioplasty using the same balloon or another appropriately oversized balloon by 1mm will be used for an additional 2 minutes. A final angiogram will be obtained for documentation.

Device: Conventional PTA

Drug Eluting Balloon (DEB)

EXPERIMENTAL

Treatment arm 2 - Conventional Balloon with DEB A Conventional balloon is used to pre-dilate the target lesion. The DEB of a similar diameter to the conventional balloon used is then inflated across the stenosis. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 1 minute. A final angiogram will be obtained for documentation. The drug coated on the DEB is Paclitaxel.

Device: Drug Eluting Balloon (DEB)

Interventions

Conventional PTA DEVICE

Use of conventional balloon for angioplasty only

Also known as: REEF angioplasty balloon (Manufacturer Medtronic)

Conventional PTA only

Drug Eluting Balloon (DEB) DEVICE

Use of DEB after conventional balloon angioplasty

Also known as: IN.PACT ADMIRAL Paclitaxel-eluting Balloon (Medtronic)

Drug Eluting Balloon (DEB)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Upper limb or groin AVF/AVG
• The AVF/AVG is \> 3 months old.
• Native vessel measures between 4 to 7 mm diameter (corresponding to the sizes of available DEBs).
• The fistula or graft must not be thrombosed.
• Able to cross with guide wire
• Platelet count \>50,000/l (platelet infusion if \<100,000/l)
• PT/PTT not more than 3 seconds above normal (FFP infusion for abnormal PT/PTT)

You may not qualify if:

• Uncorrectable coagulopathy (despite transfusion) or hypercoagulable state.
• Evidence of systemic infection or a local infection associated with the fistula or graft.
• The patient is \< 21 years of age.
• The patient is pregnant.
• Patient is enrolled in another investigational study
• Patient has comorbid conditions that may limit their ability to comply with the follow-up requirement.
• Life expectancy \< 6 months

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169068, Singapore

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Farah G Irani, MBBS,FRCR

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

SG (1)