A Real-world Registry Investigating Sirolimus-coated Balloon Versus Paclitaxel-coated Balloon Angioplasty for the Treatment of Dysfunctional Arteriovenous Fistula (SAVE AVF)

April 11, 2022 updated by: Singapore General Hospital

Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can induce vascular injury and accelerate intimal hyperplasia, resulting in rapid restenosis and need for repeated procedure to maintain vessel patency. The anti-proliferative drug that is coated on the surface of balloon is released to the vessel wall during balloon angioplasty and blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty. Additionally, unlike stents, DCB does not leave a permanent structure that may impede future surgical revision. Recent randomized control trials (RCT) have shown the superiority of paclitaxel durg-coated balloon (PDCB) over POBA in the treatment of stenosis in AVFs. In a large multicenter RCT, PDCB was demonstrated to result in a 6-month target lesion primary patency of 82.2% compared to 59.5% for POBA. However, concerns had also arisen recently in the use of PDCB. In large lower limb studies involving the use of paclitaxel devices, meta-analysis by Katsanos et al had revealed increased late risk mortality in patient that are treated with PDCB or paclitaxel-coated stent.

Sirolimus drug-coated balloon (SDCB) is the new generation of drug eluting balloons that are available in the market. Compared to paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. The effectiveness of SDCB in patients with dialysis access dysfunction has been shown in a small pilot study in AVF stenosis and AVG thrombosis. SAVE AVF registry ams to assess the efficacy and safety of SDCB vs PDCB angioplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

  • Singapore
      • Singapore, Singapore, 169856
        • Recruiting
        • Singapore General Hospital
        • Contact:
        • Principal Investigator:
          • Tjun Yip Tang
        • Principal Investigator:
          • Ru Yu Tan
        • Principal Investigator:
          • Apoorva Gogna

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with dysfunctional AVFs who have undergone balloon angioplasty or thrombolysis with PDCB or SDCB.

Description

Inclusion Criteria:

  • Age 21-85 years
  • Patient who required balloon angioplasty for dysfunctional or thrombosed AVF
  • Successful thrombolysis and angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included in no treatment is required.
  • received either PDCB or SDCB for the treatment of stenosis.

Exclusion Criteria:

  • Patient unable to provide informed consent
  • Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty
  • Patients who had underwent stent placement within the AVF circuit
  • Sepsis or active infection
  • Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
  • Allergy to iodinated contrast media, heparin, paclitaxel or sirolimus
  • Pregnancy
  • Inadequate treatment of underlying stenosis, defined as >= 30% residual stenosis of the underlying lesions.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AVFs treated with Sirolimus Drug Coated Balloon
Dysfunctional matured AVF that have underwent thrombolysis or balloon angioplasty with SDCB within 6 months witll be considered for the registry.
Device: Sirolimus Drug Coated Balloon
AVFs treated with SDCB
AVFs treated with Paclitaxel Drug Coated Balloon
Dysfunctional matured AVF that have underwent thrombolysis or balloon angioplasty with PDCB within 6 months witll be considered for the registry.
Device: Paclitaxel Drug Coated Balloon
AVFs treated with PDCB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circuit Primary Patency Rate at 6 months
Time Frame: 6 months post-op
Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm.
6 months post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circuit Primary Patency at 12 months
Time Frame: 12 months post-op
Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm.
12 months post-op
Target Lesion Restenosis
Time Frame: 6 and 12 months post-op
Incidence of stenosis >50% diameter of adjacent reference vessel segment from angiography images
6 and 12 months post-op
Number of repeat interventions to treated 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
This will include interventions to treated lesion
6 and 12 months post-op
Target lesion revascularization free interval
Time Frame: 12 months post-op
Interval from intervention to repeat clinically driven target lesion reintervention
12 months post-op
Complication rates of the procedure
Time Frame: Time of procedure
Categorised according to SIR definitions (Aruny et al)
Time of procedure
Mortality rates of patients
Time Frame: 6 and 12 months post-op
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: Tjun Tip Tang, Singapore General Hospital
  • Principal Investigator: Ru Yu Tan, Singapore General Hospital
  • Principal Investigator: Apoorva Gogna, 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

Helpful Links

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 (Anticipated)

April 18, 2022

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/2014

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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