Shockwave’s Disrupt BTK II Postmarket Study Commences Enrollment

November 22, 2021—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced the start of the Disrupt BTK II postmarket study to assess the safety, effectiveness, and optimal clinical use of the Shockwave Peripheral IVL System for the treatment of calcified peripheral lesions below the knee (BTK), including some of the most challenging patients with critical limb ischemia (CLI).

Disrupt BTK II is a postmarket, prospective, multicenter, single-arm study that is expected to enroll 250 patients at 40 sites globally. Patients will be followed for 2 years to assess the long-term durability of IVL in this difficult to treat patient population.

The primary effectiveness endpoint of Disrupt BTK II is procedural success, defined as ≤ 50% residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure), as assessed by an independent angiographic core lab. The study will assess the absence of major adverse limb events within 30 days of the index procedure as a primary safety endpoint.

The Disrupt BTK II study is being led by Ehrin Armstrong, MD, Medical Director and Interventional Cardiologist at Adventist Heart & Vascular Institute in St. Helena, California, and Venita Chandra, MD, Vascular Surgeon and Clinical Associate Professor, Division of Vascular Surgery, at Stanford Health Care in Stanford, California. The first patient in the study was enrolled by Nicolas Shammas, MD, at Midwest Cardiovascular Research Foundation in Davenport, Iowa.

“Patients with severely calcified, diffuse BTK disease, and especially those with CLI, are often in severe pain with limited treatment options to achieve adequate arterial revascularization,” commented Dr. Armstrong in Shockwave Medical’s press release. “The unmet clinical need for this population is extremely high. Disrupt BTK II will further evaluate how IVL may be optimally used to treat patients who have historically been excluded from most endovascular treatment trials.”

Dr. Chandra added, “More and more patients with CLI also present with end-stage renal disease, advanced diabetes, or other comorbidities that impact their overall health and our ability to effectively treat their CLI. We already know that IVL can reduce significant dissection as well as reduce the need for provisional stenting over conventional percutaneous transluminal angioplasty in peripheral vessel beds, but what makes Disrupt BTK II even more exciting is that we are now isolating the treatment effect to get a clearer picture about what role IVL can offer as a definitive therapy for these very complex patients.”