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

Arteriovenous Fistula Stenosis Clinical Trial

— CONCERTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05961852
• Other study ID #: CONCERTO
• Status: Completed
• Phase: Phase 1
• Start date: August 15, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2023
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Constriction, Pathologic
• Fistula

Intervention

Device:
• Angioplasty
Angioplasty with cutting and drug-coated balloon

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion primary patency	Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.	6 months after index procedure