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Clinical Trials/NCT05961852
NCT05961852CompletedPhase 1

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

Singapore General Hospital2 sites in 1 country19 target enrollmentStarted: August 15, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
19
Locations
2
Primary Endpoint
Target lesion primary patency
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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