FDA approves trial to test percutaneous procedure for PAD

PQ Bypass has received an investigational device exemption from the FDA to initiate the first pivotal clinical trial of percutaneous femoropopliteal bypass for patients with peripheral artery disease (PAD), according to a press release.

The procedure—performed with PQ Bypass’s DETOUR system—allows for long blockages in the superficial femoral artery to be bypassed so blood flow can be restored to the lower legs and feet of patients. Up to 292 patients with lower limb ischemia and lesions greater than 15 centimeters caused by PAD will be enrolled at up to 40 sites in the DETOUR II trial.

“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. Until now, endovascular methods of treating these long lesions have not been comparable to open bypass surgery,” Sean P. Lyden, MD, a Cleveland Clinic vascular surgeon and national co-principal investigator of DETOUR II, said in the release.

“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 centimeters in length, and we look forward to continuing to study this procedure with the commencement of DETOUR II.”

The trial will evaluate clinical safety and effectiveness as well as economic data such as procedural and follow-up costs, including rehospitalizations through two years. PQ Bypass said the procedure is designed to provide the durability of open surgery with a less-invasive approach for treating long lesions.