Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III) (NCT02923193) | Clinical Trial Compass
CompletedNot Applicable
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
United States306 participantsStarted 2017-02-22
Plain-language summary
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study 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. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.
In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.
The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.
A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.
Results for the observational study will be reported in a separate record under NCT05881421.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 greater than or equal to 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.
✓. Target lesion that is located in a native, de novo superficial femoral artery (SFA) or popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).