Esprit BTK Post-Approval Study

Inclusion Criteria:

• General Inclusion Criteria

1. Subject must provide written informed consent prior to any study-specificprocedures which are not considered standard of care at the site.

2. Informed consent can be obtained up to 3 days post-procedure or prior todischarge whichever comes first.

3. Subject, or a legally acceptable representative must provide writteninformed consent per site IRB/EC requirements.

4. Subject must be at least 18 years of age.

5. 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 vesseldiameter ≥ 2.5 mm and ≤ 4.0 mm.

2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time ofthe procedure. If needed, quantitative imaging (angiography and intravascularimaging) can be used to aid accurate sizing of the vessels.

Exclusion Criteria:

• General Exclusion Criteria

1. Subjects who have contraindications to the Esprit BTK System per theinstruction for use (IFU).

2. Subject is currently participating in another clinical investigation that hasnot yet completed its primary endpoint.

3. Subject or Legally Acceptable Representative (LAR) is unable or unwilling toprovide 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 ofthe 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 a metallicstent as part of a planned treatment or a bailout in the target vessel duringthe index procedure.

2. Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.