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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05961852
Recruitment Status : Completed
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : August 15, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05961852


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 168609
Sponsors and Collaborators
Singapore General Hospital
National Medical Research Council (NMRC), Singapore
Investigators
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Principal Investigator: Kun Da Zhuang, MBBS Singapore General Hospital
More Information
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Publications:

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT05961852    
Other Study ID Numbers: CONCERTO
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
arteriovenous fistula
drug-coated balloon
cutting balloon
stenosis
Additional relevant MeSH terms:
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Arteriovenous Fistula
Constriction, Pathologic
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities