COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-06-30

Brief Summary

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To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

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Detailed Description

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This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having \> 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.

The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.

Conditions

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Arteriovenous Fistula Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

Cutting and drug-coated balloon angioplasty

Group Type EXPERIMENTAL

Angioplasty

Intervention Type DEVICE

Angioplasty with cutting and drug-coated balloon

Interventions

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Angioplasty

Angioplasty with cutting and drug-coated balloon

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Failing mature upper limb AVF
2. Resistant stenosis (\>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
3. Patient is \>= 21 years of age
4. Ability to provide informed consent

Exclusion Criteria

1. Thrombosed AVF
2. Target lesion has a sharp angle (\> 45 degrees)
3. Lesions requiring cutting balloon size \> 7 mm
4. Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
5. Contraindication to dual antiplatelet therapy
6. Severe allergy to contrast media that cannot be adequately managed for the procedure
7. Breast-feeding and/or pregnant females
8. Male patients who are planning to father children during the trial period
9. Unable to comply with follow up protocol (for instance, limited life expectancy)

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No