Esprit BTK Post-Approval Study

Open to people ages 18 years and up

• 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).