Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
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 that has not yet completed its primary endpoint.
3. Subject or Legally Acceptable Representative (LAR) 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.
1. Subject has in-stent restenosis in the target vessel or requires a metallic stent as part of a planned treatment or a bailout in the target vessel during the index procedure.
2. Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.
