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

Sponsor

Singapore General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05961852

Collaborator

National Medical Research Council (NMRC), Singapore (Other)

Enrollment

Location

Arm

10.5

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arteriovenous Fistula Stenosis	Device: Angioplasty	Phase 1

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

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 15, 2018

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment arm Cutting and drug-coated balloon angioplasty	Device: Angioplasty Angioplasty with cutting and drug-coated balloon

Arm

Intervention/Treatment

Experimental: Treatment arm

Cutting and drug-coated balloon angioplasty

Device: Angioplasty

Angioplasty with cutting and drug-coated balloon

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)