Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Singapore
Singapore General Hospital
RECRUITING
Singapore
Contact Information
Primary
Arjunana Sarupraba
arjunana.sarupraba@sgh.com.sg
6222 3322
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 94
Treatments
Experimental: Drug-coated balloon
Ranger drug-coated balloon will be used for all peripheral AVF stenosis.
Active_comparator: Conventional balloon
Conventional balloon will be used for all peripheral AVF stenosis.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation, Singapore Clinical Research Institute
Leads: Singapore General Hospital