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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05961852

Acronym

CONCERTO

Enrollment

Registered

2023-07-27

Start date

2018-08-15

Completion date

2019-06-30

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula Stenosis

Keywords

arteriovenous fistula, drug-coated balloon, cutting balloon, stenosis

Brief summary

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

Detailed 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.

Interventions

DEVICEAngioplasty

Angioplasty with cutting and drug-coated balloon

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Target lesion primary patency	6 months after index procedure	Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026