ACOART BTK RENEW:A Post Market Clinical Study
Recruiting
N/A
Interventional Study
Peripheral Artery Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 107 (estimated)
- Sponsor
- Acotec Scientific Co., Ltd · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 1\. Age ≥18 years old and ≤75 years old
* 2\. Rutherford clinical category classification:3,4 or 5
* 3\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
* 4\. Reference vessel dia…
Contacts