Trials / Unknown
UnknownNCT05088083
Paclitaxel-Coated Balloon for the Treatment of AVF
Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 143 (estimated)
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon | After predilation, using drug-coated balloon catheter to cover the whole treated segment |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2023-03-01
- Completion
- 2023-09-01
- First posted
- 2021-10-21
- Last updated
- 2021-10-21
Source: ClinicalTrials.gov record NCT05088083. Inclusion in this directory is not an endorsement.