Clinical trial NCT04885985: ACOART BTK RENEW：A Post Market Clinical Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-05-13
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 diameter is between 2 mm and 4 mm
* 5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

Exclusion Criteria:

* 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.
* 5. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
* 6. Life expectancy \< 5 year.
* 7. Cumulative length of 100% occluded target lesion(s)\>150 mm
* 8. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
* 9. History of stroke within 90 days prior to enrollment
* 10. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
* 11. Uncorrectable bleeding diathesis
* 12. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
* 13. Pregnant or breastfeeding female subjects
* 14. Ability to cross a guidewire through target lesion
* 15. Patients who have participated in clinical trials of other medical devices or drugs during the same period

Primary outcomes:
measure: Primary Patency
timeFrame: 6 month
Secondary outcomes:
measure: Major adverse event (MAE) rate
timeFrame: 30 days
measure: Patency rate
timeFrame: 12 months,24 months,36 months,48 months ,60 months
measure: Rate of major target limb amputation
timeFrame: 12 months,24 months,36 months,48 months ,60 months
measure: Rate of All-cause mortality
timeFrame: 12 months,24 months,36 months,48 months ,60 months
measure: Rate of clinically-driven target vessel revascularization (CD-TVR)
timeFrame: 12 months,24 months,36 months,48 months ,60 months
measure: Rate of clinically-driven target lesion revascularization (CD-TLR)
timeFrame: 12 months,24 months,36 months,48 months ,60 months
measure: Rate of ulcer healing
timeFrame: 12 months,24 months,36 months,48 months ,60 months
measure: Rate of distal embolization
timeFrame: through procedure completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chui Yang Liu Hospital affiliated to Tsinghua University
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Zhuang Baixi
role: PRINCIPAL_INVESTIGATOR
References: