Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

NCT06553443 | Recruiting Phase 3 FDA Device

• 1 other identifier: RANGER
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

Conditions

Arteriovenous Fistula; Arteriovenous Fistula Stenosis; Dialysis Access Malfunction

Keywords

drug-coated balloon; access circuit patency

Outcome Measures

Primary Outcomes (1)

• Access circuit primary patency

  Time to next clinically-driven intervention

  6 months

Secondary Outcomes (5)

• Access access circuit patency

  12 months

• Access circuit assisted primary patency

  6 and 12 months

• Access circuit secondary patency

  6 and 12 months

• Procedural complication

  12 months

• Mortality

  12 months and 5 years

Study Arms (2)

Drug-coated balloon

EXPERIMENTAL

Ranger drug-coated balloon will be used for all peripheral AVF stenosis.

Device: Angioplasty of all peripheral AVF stenosis

Conventional balloon

ACTIVE COMPARATOR

Conventional balloon will be used for all peripheral AVF stenosis.

Device: Angioplasty of all peripheral AVF stenosis

Interventions

Angioplasty of all peripheral AVF stenosis DEVICE

All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Conventional balloon; Drug-coated balloon

Eligibility Criteria

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

You may qualify if:

• Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
• AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
• Less than 30% residual stenosis after angioplasty.
• ≥ 21 years old
• Informed and valid consent given.

You may not qualify if:

• Thrombosed AVFs
• Haemodynamically significant central vein stenosis
• Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
• Contraindication to antiplatelet therapy
• Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
• Allergy / contraindication to paclitaxel.
• Acute infection over proposed puncture site.
• Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study.
• Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
• Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singapore Clinical Research Institute: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

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

Central Study Contacts

Arjunana Sarupraba

CONTACT

6222 3322; arjunana.sarupraba@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All are blinded except procedurist and protocol administrator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: January 4, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

SG (1)