Acotec DCB Post Market Clinical Follow-up

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-poplitealarteries 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 thePMCF, understands the purpose of this PMCF and agrees to comply with allprotocol-specified examinations and follow-up appointments.

5. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 havegone 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 thatwould 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 adequatecontraceptives or currently lactating.

9. Other comorbidities, which in the opinion of the investigator limit longevityor likelihood of compliance with protocol follow up.

10. Myocardial infarction or stroke within 30 days prior to index procedure.