NCT06422845

Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: DK Medical Technology (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.

Detailed description

This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter.

Conditions

• Arteriovenous Fistula Stenosis

Interventions

Type	Name	Description
DEVICE	Dissolve AV Peripheral Scoring Drug-coated Balloon	Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon

Timeline

• Start date: 2024-09-30
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-05-21
• Last updated: 2025-01-09

Locations

33 sites across 1 country: China