PQ Bypass Receives IDE to Initiate DETOUR II Pivotal Trial
December 13, 2017—PQ Bypass, Inc. announced it has received conditional approval of its investigational device exemption from the US Food and Drug Administration to initiate the DETOUR II clinical trial. The pivotal DETOUR II trial will evaluate the safety and effectiveness of the company's Detour system for percutaneous femoropopliteal bypass in up to 292 patients with lower limb ischemia caused by long blockages (> 15 cm) in the superficial femoral artery.
According to PQ Bypass, DETOUR II is a prospective, single-arm, global multicenter trial that will be conducted at up to 40 sites to enable the collection of safety and effectiveness data in support of a premarket approval submission to the US Food and Drug Administration. To demonstrate health economic outcomes, the trial also includes a prospective economic study designed to collect data related to the costs associated with treating peripheral artery disease in the study population. An economics core lab will lead the collection of quality-of-life outcome measures (collected at baseline, 30 days, 6 months, and 12 months) and procedural and follow-up costs, including rehospitalizations, through 24 months.
The PQ Bypass Detour system is composed of the Torus stent graft, Detour crossing device, and Detour snare.
In January 2017, PQ Bypass announced that the DETOUR I trial had met its primary safety and efficacy endpoints. Professor Dierk Scheinert, MD, presented the data at LINC 2017, the Leipzig Interventional Course, in Leipzig, Germany. PQ Bypass received European CE Mark approval for all three devices that are included in the Detour system in March 2017.
Sean P. Lyden, MD, and Jihad A. Mustapha, MD, are National Co-Principal Investigators of the DETOUR II trial. Dr. Lyden is professor and Chairman of the Department of Vascular Surgery, Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic in Cleveland, Ohio. Dr. Mustapha is clinical associate professor of medicine, Michigan State University College of Osteopathic Medicine in East Lansing, Michigan.
"Patients with life-limiting claudication or critical limb ischemia typically have lesions longer than 15 cm, and we know that lesion length is directly proportional to patency,"commented Dr. Lyden in the company's announcement. "Until now, endovascular methods of treating these long lesions have not been comparable to open bypass surgery. The Detour procedure is designed to treat patients with severely calcified or long-segment disease. It’s essentially a femoropopliteal bypass with polytetrafluoroethylene, but done percutaneously. The DETOUR I trial in Europe demonstrated safety and efficacy in patients with lesions as long as 44 cm, and we look forward to continuing to study this procedure with the commencement of DETOUR II."
Dr. Mustapha added, "The Detour system features a truly innovative, intuitive design and the trial will investigate its benefits in addressing long lesions that are not well served by existing minimally invasive approaches. We look forward to working with the DETOUR II trial clinical sites on this important research."