Trial Purpose and Description
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty followed DCB versus DCB with standard balloon pre-dilatation for the treatment of moderate and severely calcified femoropopliteal arteries. Up to 300 subjects (150 per treatment arm) will be enrolled and treated to yield 240 evaluable subjects complete the study assuming a 20% lost to follow-up rate.
Ages: 18 years and older
- Subject is able and willing to comply with all assessments in the study.
- 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.
- Age of subject is > 18.
- Rutherford Clinical Category 2, 3, or 4 of the target limb.
- Estimated life expectancy >1 year.
- Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guideline.
- Subject is intended to undergo treatment with Lithoplasty followed by DCB or DCB with standard balloon pre-dilatation.Angiographic Inclusion Criteria
- Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal
- Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
- Target lesion is ≥70% stenosis by investigator via visual estimate.
- Target lesion length is 50-180mm for lesions 70-99% stenosed. Target lesion can be all or part of the 180mm treated zone.
- Chronic total occlusion lesion length is ≤100mm.
- Subject has at least one patent tibial vessel on the target leg with runoff to the foot, defined as no stenosis >50%.
- 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.
Rutherford Clinical Category 0, 1, 5 and 6. 2. Subject has active infection requiring antibiotic therapy. 3. Planned target limb major amputation (above the ankle). 4. History of prior endovascular or surgical procedure on the index limb within the past 30 days or planned within 30 days of the index procedure.
5. Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter.
6. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 7. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
8. Subject has known allergy to urethane, nylon, or silicone. 9. Myocardial infarction within 60 days prior to enrollment. 10.History of stroke within 60 days prior to enrollment. 11.History of thrombolytic therapy within two weeks of enrollment. 12.Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L), or on dialysis.
13.Subject is pregnant or nursing. 14.Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
15.Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
16.The use of specialty balloons, re-entry or atherectomy devices.
Angiographic Exclusion Criteria 17.In-stent restenosis within the target zone. 18.Lesions extending from common femoral to superficial femoral artery or within 10 mm of the ostium of the anterior tibial artery.
19.Evidence of aneurysm or thrombus in target vessel. 20.No calcium or mild calcium in the target lesion. 21.Target lesion within native or synthetic vessel grafts. 22.Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
23.Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to target site at the time of the index procedure.
24.Unable to pass the guidewire across the target lesion.
Shockwave Medical Inc.
Dates: 05/02/2017 - 04/30/2018
Last Updated: 02/22/2018
Study HIC#: 2000020571