Clinical Trial

Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

Study acronym: DKTAVG
Recruiting
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Summary
This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure balloon in treating such lesions, so as to provide a basis for optimizing the treatment of such lesions. This study will be conducted in seven (7) clinical trial institutions, with a total of 140 subjects included. After randomization, the subjects will use either the scoring balloon dilatation catheter, developed and produced by DK Medical Technology Co., Ltd., or the peripheral balloon dilatation catheter for surgical treatment. Clinical follow-up will be carried out within 5 days, 3 months, 6 months, and 12 months after the procedure.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-10.
Status change: Not Yet Recruiting → Recruiting 2025-01-07
Trial Details
NCT Number NCT06503692
Lead Sponsor DK Medical Technology (Suzhou) Co., Ltd.
Conditions Arteriovenous Graft Stenosis
Enrollment 140 participants
Start Date 2024-08-13
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-09