HVP_Disrupt PAD III
HVP Disrupt PAD III (Shockwave)
The objective of the randomized study is to assess the safety and effectiveness of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries.
Key Inclusion Criteria:
1. Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
2. Age of subject is > 18.
3. Rutherford Clinical Category 2, 3, or 4 of the target limb.
4. Estimated life expectancy >1 year.
5. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
6. Subject is intended to undergo treatment with Lithoplasty followed by DCB or DCB with standard balloon pre-dilatation.
Angiographic Inclusion Criteria
7. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal
8. Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
9. Target lesion is ≥70% stenosis by investigator via visual estimate.
10. Target lesion length is 50-180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
11. Chronic total occlusion lesion length is ≤100mm.
12. Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.
13. 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.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Heart and Vascular
Peripheral Artery Disease
Ethan Korngold MD
Shockwave Medical, Inc.
- Providence Portland Medical Center
- Providence St. Vincent Medical Center