Trials / Unknown
UnknownNCT06029569
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- Sponsor
- Shanghai Bomaian Medical Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Detailed description
To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Rapamycin drug balloon angioplasty | Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula. |
| PROCEDURE | Paclitaxel drug balloon angioplasty | Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula. |
Timeline
- Start date
- 2023-09-15
- Primary completion
- 2025-09-15
- Completion
- 2025-12-15
- First posted
- 2023-09-08
- Last updated
- 2023-09-08
Source: ClinicalTrials.gov record NCT06029569. Inclusion in this directory is not an endorsement.