Percutaneous femoropopliteal bypass system shows feasibility in early study

LAS VEGAS — A percutaneous femoropopliteal bypass system appears to be feasible, according to interim results of a CE Mark trial presented at VIVA 15.

Traditionally, surgical bypass has been required for revascularization of long-segment lesions in superficial femoral arteries, and while endovascular approaches have been developed, they could improve durability, Dainis Krievins, MD, PhD, from Pauls Stradins Clinical University Hospital, Riga, Latvia, said during a press conference.

Dainis Krievins

A new system (PQ Bypass, PQ Bypass Inc.) was developed for percutaneous revascularization of these challenging lesions by facilitating bypass with a modular stent graft system, in which the adjacent femoral vein is used as a conduit, he said.

A prospective, single-arm, multicenter trial of up to 60 patients in Chile, Germany, Latvia and Poland with superficial femoral artery lesions of 10 cm to 30 cm and Rutherford classification of 3 to 5 is underway in order to prove the feasibility of the system and to enable it to be considered for a CE Mark, according to Krievins.

The primary safety endpoint is freedom from MACE at 6 months and the primary performance endpoints include primary patency at 6 months and systemic vascular resistance > 2.5 as adjudicated by an independent core lab, according to Krievins.

At VIVA 15, he reported data from the first 15 patients enrolled in Latvia (mean follow-up, 3.2 months). Average device time was 81 minutes and average procedure time was 126 minutes, he said.

The technical success rate in these patients was 100%, as was the stent-grant patency at current follow-up, he said. No patients had venous symptoms and only two had adverse events: one skin-related adverse event as a reaction to clopidogrel, and one case of reperfusion edema up to a duration of 2 weeks, he added.

“This technique looks promising,” he said. “Percutaneous femoral bypass for long-segment [superficial femoral artery] disease is feasible, and of course we need more data.” ˗ by Erik Swain

Reference:

Krievins D, et al. Late-Breaking Clinical Trials. Presented at: VIVA 15; Nov. 2-5, 2015; Las Vegas.

Disclosure: Krievins reports serving as an investigator for the PQ Bypass CE Mark trial.