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Completed

NCT Number: NCT05961852

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

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

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Key information

Conditions

Arteriovenous Fistula Stenosis Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Singapore General Hospital

Singapore, 168609

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Failing mature upper limb AVF
  • 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)
  • Patient is >= 21 years of age
  • Ability to provide informed consent

Exclusion criteria

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

Treatment and study plan

Angioplasty

Device

Angioplasty with cutting and drug-coated balloon

Primary outcomes

  1. Target lesion primary patency

    Time frame: 6 months after index procedure

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

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Acronym: CONCERTO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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