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

July 17, 2023 updated by: Singapore General Hospital
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168609
        • Singapore General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

  • Principal Investigator: Kun Da Zhuang, MBBS, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONCERTO (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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