Global DISRUPT PAD III Trial Will Evaluate Shockwave Medical's Lithoplasty System Combined With DCB Therapy in Calcified PAD

November 1, 2016—Shockwave Medical announced plans for the DISRUPT PAD III multicenter randomized trial that will exclusively enroll patients with calcified peripheral artery disease (PAD) to assess short- and long-term outcomes of the company’s Lithoplasty system in combination with drug-coated balloon (DCB) therapy compared to traditional percutaneous transluminal balloon angioplasty (PTA) before DCB treatment in a calcified patient population.

According to the company, DISRUPT PAD III will compare the safety and effectiveness of Lithoplasty followed by DCB versus DCB with standard predilatation for the treatment of moderately and severely calcified femoropopliteal arteries. The In.Pact Admiral DCB (Medtronic) will be used in both treatment arms.

The primary endpoint of the study will be acute procedural success without the need for stents, and the secondary endpoint will be primary patency at 12 months. Up to 300 patients will be enrolled at 45 centers in the United States, Europe, and New Zealand beginning in early 2017.

William Gray, MD, who serves as Principal Investigator of DISRUPT PAD III, commented in the company’s press release, “Most contemporary randomized studies in PAD have excluded calcified lesions. The available data on this difficult-to-treat patient cohort largely comes from post hoc subset analyses of single-arm registries. DISRUPT PAD III will be an important study because it will provide physicians foundational Level 1 evidence to guide treatment of this difficult-to-treat patient cohort. Today, there is no clear standard of care for interventional treatment of calcified peripheral artery disease.” Dr. Gray is System Chief, Division of Cardiovascular Disease at Main Line Health and President, Lankenau Heart Institute in Wynnewood, Pennsylvania.

The company noted that previous DISRUPT PAD studies used Lithoplasty as primary therapy, demonstrating safe, effective, and consistent revascularization of calcified lesions while maintaining future treatment options. To date, the potential benefit of combination therapy in these patients has not yet been evaluated.

In September, Shockwave Medical announced that the Shockwave Medical Lithoplasty system received clearance from the US Food and Drug Administration (FDA) for use in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries.

On September 19, the company announced 6-month follow-up data from the 95-patient, single-arm DISRUPT PAD study that evaluated Lithoplasty as a stand-alone primary therapy. The study demonstrated that Lithoplasty is safe and that the results are consistent and effective in the treatment of patients with calcified lesions. Principal Investigator Prof. Thomas Zeller, MD, presented the data at VIVA 16, the Vascular InterVentional Advances annual conference in Las Vegas, Nevada.

The peripheral Lithoplasty system is commercially available in the European Union and the United States for treatment of peripheral vascular disease, advised the company.