Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-04

Study Completion Date

2029-12-31

Brief Summary

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To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

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Detailed Description

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This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.

The primary outcome measure is 6-month access circuit patency.

Conditions

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Arteriovenous Fistula Arteriovenous Fistula Stenosis Dialysis Access Malfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

All are blinded except procedurist and protocol administrator.

Study Groups

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Drug-coated balloon

Ranger drug-coated balloon will be used for all peripheral AVF stenosis.

Group Type EXPERIMENTAL

Angioplasty of all peripheral AVF stenosis

Intervention Type DEVICE

All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Conventional balloon

Conventional balloon will be used for all peripheral AVF stenosis.

Group Type ACTIVE_COMPARATOR

Angioplasty of all peripheral AVF stenosis

Intervention Type DEVICE

All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Interventions

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Angioplasty of all peripheral AVF stenosis

All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
3. Less than 30% residual stenosis after angioplasty.
4. ≥ 21 years old
5. Informed and valid consent given.

Exclusion Criteria

1. Thrombosed AVFs
2. Haemodynamically significant central vein stenosis
3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
4. Contraindication to antiplatelet therapy
5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
6. Allergy / contraindication to paclitaxel.
7. Acute infection over proposed puncture site.
8. Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study.
9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No