Trials / Recruiting
RecruitingNCT06503692
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DKutting PTA Scoring Balloon Dilatation Catheter | The device consists of a balloon catheter with scoring elements (triangular cross-section) fixed to the surface of the balloon and distributed radially at every 120°. When the balloon is inflated, the expansion force is focused along the scoring elements, causing it to expand under lower balloon pressure. |
| DEVICE | Peripheral Balloon Catheter | The device is an over-the-wire (OTW) double-lumen balloon catheter. The balloon is inflated to a known diameter at a specified pressure. |
Timeline
- Start date
- 2024-08-13
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2024-07-16
- Last updated
- 2025-01-09
Locations
7 sites across 2 countries: China, Singapore
Source: ClinicalTrials.gov record NCT06503692. Inclusion in this directory is not an endorsement.