Clinical Data

Clinical Evaluations of Intravascular Lithotripsy (IVL) Technology

Trial Name
Status

DISRUPT PAD I & II

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 was 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 IVL System. Treatment resulted in a low residual stenosis. 6 month data is now available.

DISRUPT PAD III

Enrolling
This prospective, multi-center, single arm, study to assess Shockwave IVL in treating calcified, stenotic, peripheral arteries in a real-world claudicant or CLI population. DISRUPT PAD III will study use of Shockwave Medical IVL System in combination with drug coated balloon (DCB) therapy to assess short- and long-term outcomes compared to those achievable using traditional balloon angioplasty (PTA) prior to DCB in a calcified patient population.

A total of 334 subjects (167 per treatment arm) will be enrolled in the study with procedural success being defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab. Enrollment began in April 2017 and is expected to be completed in April 2020.

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. A maximum of 250 subjects at the same 50 sites will be enrolled in the observational study. Procedural success defined as residual stenosis <30% prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 16 months. Subjects in the observational study will be followed through hospital discharge.

DISRUPT BTK

Complete
The DISRUPT BTK study is a single arm, prospective, multi-center study that enrolled 20 subjects with with heavily calcified symptomatic (Rutherford 3 to 5) infrapopliteal lesions.

The performance endpoint, was defined as acute reduction in residual diameter stenosis. The 30-day, 6 month, and 12 month secondary endpoints include the ability of the Shockwave IVL System to achieve a post-shockwave residual diameter stenosis of ≤50%.

Enrollment was completed in July, 2017. The study demonstrated compelling safety and performance results with the IVL System. 30-day data is now available.