Acotec DCB Post Market Clinical Follow-up

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.

• 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. (Device): 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

Primary outcomes

• Primary efficacy endpoint - non-CLI group [12 Months]: 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).
• Primary efficacy endpoint -CLI group [6 Months]: 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.
• Primary safety endpoint- non-CLI group [30 days]: 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.
• Primary safety endpoint- CLI group [12 Months]: A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure

Secondary outcomes

• Rate of Any TLR (including clinically-driven and incidental TLR) [6 months,12 months,24 months, 36months,48 months,60 months]: Any TLR (including clinically-driven and incidental TLR) at 6,12, 24, 36, 48, 60 months post-procedure
• Rate of Target vessel revascularization (TVR) [6 months,12 months,24 months, 36months,48 months,60 months]: Target vessel revascularization (TVR) at 6, 12, 24, 36, 48, 60 months post-procedure
• Rate of Target limb revascularization [6 months,12 months,24 months, 36months,48 months,60 months]: Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure
• Rate of CD-TLR [6 months,12 months,24 months, 36months,48 months,60 months]: CD-TLR at 6, 24, 36, 48, 60 months post-procedure
• Rate of All-cause mortality [6 months,12 months,24 months, 36months,48 months,60months]: All-cause mortality at 6, 12, 24, 36, 48, 60 months post procedure
• Rate of Device- or procedure-related death [30 days, 6 months]: Device- or procedure-related death at 30 days and 6 months
• Rate of Major amputation [6 months,12 months,24 months, 36months,48 months,60 months]: Major amputation at 6, 12, 24, 36, 48, 60 months post procedure
• Rate of Technical success [Post procedure]: 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.
• Rate of Procedural success [Post procedure]: 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
• Change in Rutherford clinical category (target limb) [6 months,12 months,24 months, 36months,48 months,60 months]: Changes in Rutherford clinical category (target limb) at 6, 12, 24, 36, 48, 60 months post-procedure compared to baseline
• Rate of primary sustained clinical improvement [6 months,12 months,24 months, 36months,48 months,60 months]: Primary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, without TLR.
• Rate of secondary sustained clinical improvement [6 months,12 months,24 months, 36months,48 months,60 months]: Secondary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, including patients with TLR
• Rate of (Major) Amputation-free survival - CLI group [6 months,12 months,24 months, 36months,48 months,60 months]: (Major) Amputation-free survival at 6, 12, 24, 36, 48, 60 months post-procedure
• Rate of Minor amputation - CLI group [6 months,12 months,24 months, 36months,48 months,60 months]: Minor amputation at 6, 12, 24, 36, 48, 60 months post-procedure
• Rate of Wound healing - CLI group [60 months]: healed or not; if not, improving, stagnant,worsening
• New or recurrent wound of the target limb - CLI group [60 months]: New or recurrent wound of the target limb

Sex: All, ages: 18 Years to any

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.

• Schmidt Andrej, Principal investigator, Department of Angiology, University Hospital Leipzig