BIOLUX P-IV CHINA ( BIOTRONIK )

Inclusion Criteria

• •Age ≥ 18 years.
• •Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark) to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
• •Subject able to walk without assistive devices (e.g. walker, cane).
• •Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure; Both male and female subjects are willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
• •Signed and dated Patient Informed Consent (PIC) form.
• •Subject understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
• •Life expectancy, in the Investigator's opinion, of at least 12 months.
• •Target lesion consists of a de novo or non-stented restenotic lesion with a ≥70% diameter stenosis.
• •Lesion length≤ 200 mm.
• •Reference vessel diameter ≥ 2 mm and ≤ 7 mm by visual estimate.
• •Subject with ipsilateral/contralateral iliac disease that requires treatment during the index procedure can be included if treatment is successful (angiographic evidence of stenosis \<30%). Iliac disease should be treated firstly by marketed devices excluding drug eluted stent and drug coated balloon.
• •Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel \[posterior tibial, anterior tibial, or peroneal arteries\] is patent, defined as \< 50% diameter stenosis).
• •Complete occlusion lesion\> 100mm.
• •Target lesion is an in-stent or post-DCB restenosis or has been previously treated with bypass surgery.
• •Lesion within or adjacent to an aneurysm.
• •Acute or sub-acute thrombus in the target vessel.
• •Angiographic evidence of severe calcification.
• •Failure to successfully cross the target lesion with a guide wire.
• •Pre-dilation resulted in a major (≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis \> 70% or translesional peak gradient \> 10mm Hg.