Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shockwave Medical, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subjects intended to be treated with Shockwave Medical Lithoplasty for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
2. Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limb.
3. Age of subject is \> 18.
4. Subject of subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
5. Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \<50mm in length.
You may not be if
1. Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Lithoplasty as per Instructions for Use (IFU) or investigator's opinion.
2. Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
