Acotec DCB Post Market Clinical Follow-up

Study Overview
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Brief Summary
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All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6

Detailed Description
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To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Official Title
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All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: AcoArt Orchid (0.035), AcoArt Tulip (0.018) and AcoArt Litos (0.014) percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patient is ≥ 18 years old at the time of consent. 2. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment. 3. Lesion(s) can be treated with available AcoArt Orchid (0.035), AcoArt Tulip (0.018) and AcoArt Litos (0.014) DCB device per current IFU. 4. Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments. 5. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success. 6. Inflow lesion treated prior to target lesion treatment Exclusion Criteria: 1. Rutherford Classification Category 0, 1 2. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints 3. Inability to tolerate required antithrombotic or antiplatelet therapies. 4. Non-dilatable severely calcified lesion. 5. Known hypersensitivity/allergy to components of the investigational device 6. Un-treated acute or subacute thrombus in the target lesion. 7. Life expectancy < 1 year. 8. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating. 9. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up. 10. Myocardial infarction or stroke within 30 days prior to index procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-CLI group<br>Rutherford Clinical Category (RCC) 2-3 | Device: AcoArt Orchid (0.035), AcoArt Tulip (0.018) and AcoArt Litos (0.014) percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.<br>* All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment<br>|
| CLI group<br>critical limb ischemia，Rutherford Clinical Category (RCC) 4-6 | Device: AcoArt Orchid (0.035), AcoArt Tulip (0.018) and AcoArt Litos (0.014) percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.<br>* All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint - non-CLI group | Freedom from clinically-driven target lesion revascularization (CD-TLR) within 12 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to recurrent clinical symptoms of PAD (increase of one Rutherford class or more) and/or drop of ankle-brachial index (≥20% or >0.15 when compared with maximum early post-procedural level). | 12 Months | 
| Primary efficacy endpoint -CLI group | Freedom from clinically-driven TLR within 6 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to delayed or worsening wound healing, new or recurrent wound, or worsening Rutherford class. | 6 Months | 
| Primary safety endpoint- non-CLI group | A composite of freedom from major adverse limb events and perioperative death (MALE-POD) through 30 days after index procedure. A major adverse limb event is defined as above-ankle amputation or major reintervention (ie, new bypass graft, major surgical graft revision such as a jump graft or an interposition graft, or thrombectomy/thrombolysis) of the treated limb. | 30 days | 
| Primary safety endpoint- CLI group | A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Any TLR (including clinically-driven and incidental TLR) | Any TLR (including clinically-driven and incidental TLR) at 6,12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of Target vessel revascularization (TVR) | Target vessel revascularization (TVR) at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of Target limb revascularization | Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of CD-TLR | CD-TLR at 6, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of All-cause mortality | All-cause mortality at 6, 12, 24, 36, 48, 60 months post procedure | 6 months,12 months,24 months, 36months,48 months,60months | 
| Rate of Device- or procedure-related death | Device- or procedure-related death at 30 days and 6 months | 30 days, 6 months | 
| Rate of Major amputation | Major amputation at 6, 12, 24, 36, 48, 60 months post procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of Technical success | Technical success defined as final in-lesion residual diameter stenosis ≤50% by angiographic visual estimate at the end of the index procedure without device malfunction. | Post procedure | 
| Rate of Procedural success | Procedural success defined as technical success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or CD-TLR) prior to discharge | Post procedure | 
| Change in Rutherford clinical category (target limb) | Changes in Rutherford clinical category (target limb) at 6, 12, 24, 36, 48, 60 months post-procedure compared to baseline | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of primary sustained clinical improvement | Primary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, without TLR. | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of secondary sustained clinical improvement | Secondary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, including patients with TLR | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of (Major) Amputation-free survival - CLI group | (Major) Amputation-free survival at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of Minor amputation - CLI group | Minor amputation at 6, 12, 24, 36, 48, 60 months post-procedure | 6 months,12 months,24 months, 36months,48 months,60 months | 
| Rate of Wound healing - CLI group | healed or not; if not, improving, stagnant,worsening | 60 months | 
| New or recurrent wound of the target limb - CLI group | New or recurrent wound of the target limb | 60 months |