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

Singapore Health Services (SingHealth)

Status and phase: Completed; Phase 1

Conditions: Arteriovenous Fistula Stenosis

Treatments: Device: Angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05961852

CONCERTO

Details and patient eligibility

About

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

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Treatment arm

Experimental group

Description:

Cutting and drug-coated balloon angioplasty

Treatment:

Device: Angioplasty