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

Singapore General Hospital19 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arteriovenous Fistula Stenosis

Interventions

AngioplastyDEVICE

Angioplasty with cutting and drug-coated balloon

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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)

Locations (1)

Singapore General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Target lesion primary patency

Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.

Time frame: 6 months after index procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.