Trials / Recruiting
RecruitingNCT06205576
ACOART AVF RENEW: A Post Market Clinical Study
A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DCB catheter | Trade name of DCB catheter：Acoart Orchid＆Dhalia |
Timeline
- Start date
- 2023-02-20
- Primary completion
- 2025-12-01
- Completion
- 2027-06-01
- First posted
- 2024-01-16
- Last updated
- 2024-01-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06205576. Inclusion in this directory is not an endorsement.