Trials / Recruiting
RecruitingNCT04885985
ACOART BTK RENEW：A Post Market Clinical Study
A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 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 Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DEB catheter | Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014") |
Timeline
- Start date
- 2021-12-31
- Primary completion
- 2024-08-01
- Completion
- 2027-04-01
- First posted
- 2021-05-13
- Last updated
- 2024-08-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04885985. Inclusion in this directory is not an endorsement.