First Patients Enrolled in Pivotal DETOUR II Trial

February 22, 2018—PQ Bypass announced enrollment of the first patients in the pivotal DETOUR II trial in the United States. The trial is a prospective, multicenter, single-arm clinical trial designed to evaluate the company's Detour system for percutaneous femoropopliteal bypass.

In November 2017, PQ Bypass received conditional approval of the investigational device exemption (IDE) to conduct the trial for the Detour system in the United States. The company received European CE Mark approval for the Detour system in March 2017.

Vasili Lendel, MD, and André Paixao, MD, initiated the DETOUR II trial in the United States at Arkansas Heart Hospital in Little Rock, Arkansas, where they enrolled two patients with complete blockages in the superficial femoral artery (SFA) > 30 cm.

According to the company, the study will enroll up to 292 patients at up to 40 centers in the United States and Europe, with patient follow-up out to 36 months. The trial also includes a prospective economic study to collect quality-of-life outcome measures and cost data, including rehospitalizations. Sean P. Lyden, MD, and Jihad Mustapha, MD, serve as national Coprincipal Investigators of the DETOUR II trial.

In the PQ Bypass announcement, Dr. Lyden commented, "We are excited to start treating patients in the DETOUR II IDE trial, studying a procedure that may improve upon existing treatment options for patients with long-segment femoropopliteal disease. The DETOUR II trial is designed to provide definitive safety and effectiveness data on the new percutaneous bypass procedure, which has the potential to provide the effectiveness of open surgery through a minimally invasive endovascular approach for these challenging lesions."

Dr. Mustapha added, "Detour is an innovative yet intuitive endovascular procedure to create a bypass in a channel already provided by the body, but without performing open surgery. We look forward to working with the trial sites and, ultimately, to seeing the results from this landmark study."

PQ Bypass developed the Detour procedure as a treatment for long (> 15 cm) SFA blockages. Using the company's stent grafts, the Detour procedure creates an endovascular bypass that originates in the SFA, travels through the femoral vein, then returns into the popliteal artery. This new pathway is designed to redirect oxygen-rich blood around the diseased part of the vessel, restoring blood flow to the lower leg and foot of the patient. The Detour system was created by James Joye, DO, and Richard Heuser, MD.