ACOART BTK RENEW：A Post Market Clinical Study
ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAcotec Scientific Co., Ltd
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.
Eligibility criteria
Qualifiers
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 diameter is between 2 mm and 4 mm
Disqualifiers
1. Plasma creatinine clearance rate <30 mL/min
2. Acute vessel occlusion or acute thrombosis in target lesion
3. Planned amputation on the target limb
4. Subjects confined to bed that are completely non-ambulatory.
Trial design
Treatments tested in this trial
- DEB catheter
Treatment groups
107 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov