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Data from the CE Mark approval trial evaluating the safety and effectiveness of PQ Bypass (PQ Bypass, Inc.), a novel technique and devices for the performance of percutaneous bypass of long-segment lesions of the superficial femoral and popliteal arteries, were presented by Dainis Krievins, MD, during the second of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

The background of the study is that historically, more advanced disease of the lower extremities has been most commonly treated with open surgical bypass. Although successful, this surgical approach is not without significant potential morbidity.

Dr. Krievins noted that despite progress in endovascular treatment of lower-extremity disease, a viable long-term solution for long-segment occlusions and otherwise impassable lesions is still lacking. The goal of percutaneous femoropopliteal bypass is ultimately to achieve or exceed the durable patency rates associated with surgical bypass, but to do so with the minimally invasive technique of a percutaneous endovascular procedure.

As summarized at VIVA, the study is being conducted at 12 centers in six countries. It is a prospective premarket study that seeks to enroll 60 patients with lesions that range from 15 to 30 cm in length, have at least one vessel distal runoff, and are Rutherford category 3 through 5 in presentation. The primary safety endpoint is freedom from major adverse cardiac events at 6 months. The primary performance endpoint is patency at 6 months, assessed by duplex core lab. Dr. Krievins reported that secondary endpoints will be assessed at 12, 18, and 24 months.

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