Back to resultsCOmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO) (CONCERTO)
Primary Purpose
Arteriovenous Fistula Stenosis
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula Stenosis focused on measuring arteriovenous fistula, drug-coated balloon, cutting balloon, stenosis
Eligibility Criteria
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)
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Cutting and drug-coated balloon angioplasty
Outcomes
Primary Outcome Measures
Target lesion primary patency
Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
Secondary Outcome Measures
Full Information
NCT ID
NCT05961852
First Posted
July 17, 2023
Last Updated
July 17, 2023
Sponsor
Singapore General Hospital
Collaborators
National Medical Research Council (NMRC), Singapore
1. Study Identification
Unique Protocol Identification Number
NCT05961852
Brief Title
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
Acronym
CONCERTO
Official Title
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
National Medical Research Council (NMRC), Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula Stenosis
Keywords
arteriovenous fistula, drug-coated balloon, cutting balloon, stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
Cutting and drug-coated balloon angioplasty
Intervention Type
Device
Intervention Name(s)
Angioplasty
Intervention Description
Angioplasty with cutting and drug-coated balloon
Primary Outcome Measure Information:
Title
Target lesion primary patency
Description
Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
Time Frame
6 months after index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Da Zhuang, MBBS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
168609
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18503902
Citation
Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC. Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):877-83. doi: 10.1016/j.jvir.2008.02.016. Epub 2008 May 2.
Results Reference
background
Learn more about this trial
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
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