Esprit BTK Post-Approval Study

Eligibility Criteria

• * General Inclusion Criteria
• 1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.
• 1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
• 2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
• 2. Subject must be at least 18 years of age.
• 3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
• * Anatomic Inclusion Criteria
• 1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
• 2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.
• * General Exclusion Criteria
• 1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
• 2. Subject is currently participating in another clinical investigation.
• 3. Subject is unable or unwilling to provide written consent prior to enrollment.
• 4. Subject with life expectancy ≤ 1 year.
• 5. Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
• * Anatomic Exclusion Criteria
• 1. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
• 2. Subject had been previously treated with Esprit BTK Scaffold(s).