ACOART BTK RENEW：A Post Market Clinical Study

Study Overview
=================
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.

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

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: DEB catheter


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB catheter<br>Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm | Device: DEB catheter<br>* Trade name of DEB catheter: AcoArt Tulip (0.018) or AcoArt Litos (0.014)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse event (MAE) rate | Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR | 30 days | 
| Patency rate | Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation. | 12 months,24 months,36 months,48 months ,60 months | 
| Rate of major target limb amputation | A major adverse limb event is defined as above-ankle amputation of the treated limb | 12 months,24 months,36 months,48 months ,60 months | 
| Rate of All-cause mortality | All-cause mortality at 12, 24, 36, 48, 60 months post procedure | 12 months,24 months,36 months,48 months ,60 months | 
| Rate of clinically-driven target vessel revascularization (CD-TVR) | Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure | 12 months,24 months,36 months,48 months ,60 months | 
| Rate of clinically-driven target lesion revascularization (CD-TLR) | Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure | 12 months,24 months,36 months,48 months ,60 months | 
| Rate of ulcer healing | Ulcer healed or not; if not, improving, stagnant,worsening | 12 months,24 months,36 months,48 months ,60 months | 
| Rate of distal embolization | Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure | through procedure completion |