LegDeb2 Global Registry for Use of Legflow in Peripheral Arteries

Inclusion Criteria

• •Age ≥ 18 years or minimum age as required by local regulations.
• •Subject with documented diagnosis of lower extremities arterial disease (LEAD).
• •Angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days.
• •Positive diagnostic indication for PTA with a DEB in accordance with the Instructions For Use (IFU) of the Legflow DEB.
• •Adequate distal run-off to the ankle (at least one native calf vessel \[posterior tibial, anterior tibial, or peroneal arteries\] is patent, defined as ≤ 50% diameter stenosis) either pre-existing or successfully re- established prior to target lesion treatment.
• •Adequate inflow (≤ 50% diameter stenosis) either pre-existing or successfully re-established prior to target lesion treatment.
• •Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before enrollment.
• •Signed and dated Patient Informed Consent (PIC) form.
• •Ability and willingness to comply with the clinical investigation plan (CIP).
• •Life expectancy, in the Investigator's opinion, of at least 12 months