COmbiNing Cutting and Drug-Eluting Balloon for Resistant... | NCT05961852

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

NCT05961852

Sponsor

Singapore General Hospital

Status

Completed

Last Update Posted

Jul 27, 2023Actual

Enrollment

19Actual

Phase

Phase 1

Conditions

Arteriovenous Fistula Stenosis

Interventions

Angioplasty

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2018Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Jul 17, 2023

First Submission Date that Met QC Criteria

Jul 17, 2023

First Posted Date

Jul 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2023

Last Update Posted Date

Jul 27, 2023Actual

Name	Class
National Medical Research Council (NMRC), Singapore	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	Cutting and drug-coated balloon angioplasty	Device: Angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Angioplasty	Device	Angioplasty with cutting and drug-coated balloon	Treatment arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kun Da Zhuang, MBBS	Singapore General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Singapore General Hospital		Singapore		168609	Singapore

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18503902	Background	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.

ID	Term
D001164	Arteriovenous Fistula
D003251	Constriction, Pathologic

ID	Term
D001165	Arteriovenous Malformations
D054079	Vascular Malformations
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures