Clinical Evaluations of Lithoplasty Technology
Enrollment complete. Follow-up in progress.
The DISRUPT PAD Study is a two-phase, single arm, prospective, multicenter study that enrolled 95 patients with symptomatic (Rutherford 2 to 4) calcified femoropopliteal lesions up to 15 cm in length. The primary safety endpoint was freedom from major adverse events (MAE) through 30 days. Procedural success, the primary performance endpoint, was defined as <50% residual diameter stenosis, with or without adjunctive PTA therapy or stenting. Patency defined as <50% restenosis will be assessed at 6 months in the entire cohort and at 12 months in the 60 patient second phase of the study. The 30-day, 6 month, and 12 month secondary endpoints include freedom from clinically-driven target lesion revascularization (TLR), MAE, and functional outcomes as assessed by the walking impairment questionnaire, ABI and Rutherford Category.
Enrollment was completed in December 2015. The study demonstrated compelling safety and performance results with the Lithoplasty System. Treatment resulted in a low residual stenosis. 6 month data is now available. Learn more.