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

NCT05961852 | Completed Phase 1

• 1 other identifier: CONCERTO
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arteriovenous Fistula Stenosis

Keywords

arteriovenous fistula; drug-coated balloon; cutting balloon; stenosis

Outcome Measures

Primary Outcomes (1)

• Target lesion primary patency

  Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.

  6 months after index procedure

Study Arms (1)

Treatment arm

EXPERIMENTAL

Cutting and drug-coated balloon angioplasty

Device: Angioplasty

Interventions

Angioplasty DEVICE

Angioplasty with cutting and drug-coated balloon

Treatment arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Singapore General Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 168609, Singapore

Location

Related 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.

  PMID: 18503902 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula; Constriction, Pathologic

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Kun Da Zhuang, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: August 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

SG (1)