A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula (PREDATOR)

April 29, 2022 updated by: Singapore General Hospital

Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient with End Stage Renal Disease (ESRD). A functioning dialysis vascular access is critical to the delivery of life-saving hemodialysis (HD) treatment for these patients. Unfortunately, neointimal hyperplasia frequently occurs within the dialysis vascular access, resulting in stenosis, poor flow and thrombosis with loss of function.

The cephalic vein forms the outflow conduit for radiocephalic (RC) and brachiocephalic (BC) AVF. At the perpendicular portion of the cephalic vein, the cephalic arch is often prone to developing hemodynamically significant stenosis. The prevalence of cephalic arch stenosis is reported to be 39% in brachiocepahlic and 2% in radiocephalic AVF.

The current gold standard therapy for treatment of AVF stenosis is plain balloon angioplasty (BA). Paclitaxel coated balloon (PCB) angioplasty has also been shown recently to be superior to plain BA in the treatment of stenosis in dialysis vascular access. By releasing paclitaxel, which is an anti-proliferation drug, locally into the vessel wall during balloon contact, it will blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty.

The use of stent grafts for recurrent CAS has been demonstrated to increase patency of AVF compared to BA and bare stents. However, stent grafts are prone to edge restenosis that tend to occur within 5mm of each end of SG due to neointimal hyperplasia from the end of the stent migrating towards the center. We postulate that stent graft with PCB angioplasty of the stent edge is more effective than PCB alone in maintaining the patency of AVF with cephalic arch stenosis.

Therefore, we aim to perform a randomized controlled trial to compare the 6-month unassisted patency rate of treatment of recurrent CAS with stent graft and PCB angioplasty of both stent edge versus PCB alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia, 5042
        • Recruiting
        • Flinders Medical Center
        • Contact:
          • Chris Delaney
          • Phone Number: 0882045445
  • Singapore
      • Singapore, Singapore, 169856

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 21 - 90 years
  • Patients who requires balloon angioplasty for dysfunctional arteriovenous fistula, can be de novo lesions or recurrent CAS stenosis within six months of interventions. Suitability will be determined with a baseline ultrasound assessment.
  • Matured AVF, defined as being in use for at least 1 month prior to angioplasty
  • Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA).

Exclusion Criteria:

  • Patient unable to provide informed consent
  • Thrombosed or partially thrombosed AVF
  • Immature AVF
  • Insignificant CAS defined as <50% stenosis and no clinical indicator such as high V pressure.
  • Presence of central vein stenosis with more than 30% residual stenosis post-angioplasty
  • Patient who had underwent stent placement within the CAS previously
  • Patients who are allergic to both aspirin or clopidogrel
  • Patient who are currently enrolled in other drug eluting balloon trials
  • Sepsis or active infection
  • Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
  • Allergy to iodinated contrast media, heparin or paclitaxel
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCB Only
Cephalic arch stenosis is first treated with conventional plain balloon angioplasty. Once treated adequately (<30% residual stenosis), CAS will be treated with PCB angioplasty.
Device: Paclitaxel Coated Balloon
CAS treated with PCB only
Experimental: Stent Graft and PCB angioplasty of stent edges
CAS is first treated with conventional plain balloon angioplasty. Once treated adequately (<30% residual stenosis), CAS will be treated with PCB first to avoid geographical miss. After which, stent graft will be deployed. Length of PCB shall be long enough to cover stent edges.
Device: Paclitaxel Coated Balloon and Stent Graft
CAS treated with PCB first before deployment of stent graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency of Target Lesion (Cepahlic Arch)
Time Frame: 6-months post-op
Freedom from any re-intervention at target lesion that is clinically driven or indicated on surveillance scan
6-months post-op
Primary Patency of Access Circuit
Time Frame: 6-months post-op
Percentage of patients who do not need to undergo another re-intervention at the dialysis access circuit
6-months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Patency of Target Lesion
Time Frame: 3 and 12 months post-op
Percentage of patients who do not need to undergo another re-intervention at the target lesion
3 and 12 months post-op
Primary Patency of Access Circuit
Time Frame: 3 and 12 months post-op
Freedom from any re-intervention that is clinically driven or indicated on surveillance scan
3 and 12 months post-op
Assisted Primary Patency of Target Lesion
Time Frame: 3 and 12 months post-op
Percentage of patients who do not need to undergo another thrombolysis or thrombectomy at target lesion.
3 and 12 months post-op
Assisted Primary Patency of Access Circuit
Time Frame: 3 and 12 months post-op
Percentage of patients who do not need to undergo another thrombolysis or thrombectomy at dialysis access circuit
3 and 12 months post-op
Secondary Patency
Time Frame: 3 and 12 months post-op
Percentage of patients who will not need creation of a new AVF or an alternative dialysis access site.
3 and 12 months post-op
Time taken to next intervention
Time Frame: 12-months post-op
12-months post-op
Number of repeat interventions to target lesion
Time Frame: 6 and 12 months post-op
6 and 12 months post-op
Number of repeat interventions to maintain access circuit
Time Frame: 6 and 12 months post-op
6 and 12 months post-op
Rate of late lumen loss of the cephalic arch, proximal and distal stent edge
Time Frame: 12 months post-op
12 months post-op
Complication Rate
Time Frame: 1, 3, 6 and 12 months post-op
1, 3, 6 and 12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Tang Tjun Yip, Singapore General Hospital
  • Principal Investigator: Tan Ru Yu, Singapore General Hospital
  • Principal Investigator: Tay Kiang Hiong, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/2044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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