COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO) (CONCERTO)
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ClinicalTrials.gov Identifier: NCT05961852 |
Recruitment Status :
Completed
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arteriovenous Fistula Stenosis | Device: Angioplasty | Phase 1 |
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 (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 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment arm
Cutting and drug-coated balloon angioplasty
|
Device: Angioplasty
Angioplasty with cutting and drug-coated balloon |
- 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.
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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)
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
Singapore | |
Singapore General Hospital | |
Singapore, Singapore, 168609 |
Principal Investigator: | Kun Da Zhuang, MBBS | Singapore General Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
arteriovenous fistula drug-coated balloon cutting balloon stenosis |
Arteriovenous Fistula Constriction, Pathologic Fistula Pathological Conditions, Anatomical Arteriovenous Malformations Vascular Malformations |
Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases Congenital Abnormalities |