The first patient has been enrolled in the TORUS 2 multicentre, clinical trial, evaluating the use of the self-expanding Torus stent graft system (PQ Bypass), a novel technology designed for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery. This inaugural enrollment comes less than a month after the study received unconditional approval from the US Food and Drug Administration (FDA) for the TORUS 2 original investigative device exemption (IDE).
The TORUS 2 study (The PQ Bypass pivOtal IDE intra-aRterial stent graft study for occlUsive and re-Stenotic fem-pop revascularization) is a prospective, single-arm trial of 188 patients at up to 40 sites. The study is led by national co-principal investigators Peter Schneider (Division of Vascular and Endovascular Surgery, University of California San Francisco, USA) and Ehrin Armstrong (director of Interventional Cardiology, Rocky Mountain Regional VA Hospital; University of Colorado School of Medicine, Aurora, USA).
The objective of the trial is to evaluate the safety and effectiveness of the Torus stent graft system in the treatment of obstructive atherosclerotic lesions of the superficial femoral and/or proximal popliteal arteries. The Torus stent graft system received CE mark in 2017 for use in the DETOUR percutaneous femoropopliteal bypass procedure, based on the DETOUR 1 global study. The technology has also been evaluated in the TORUS 1 study in Europe and is currently under evaluation in the DETOUR 2 IDE for percutaneous femoropopliteal bypass in the USA and Europe.
“There is an unmet need in our care of PAD patients for an updated, optimised, and specifically designed stent graft for SFA-popliteal use,” Schneider says. “I believe this technology could become an important part of our endovascular armamentarium.”
Armstrong adds, “This study is intended to further the growing body of evidence for the TORUS stent graft. I am pleased to be involved in such an important step forward in the percutaneous treatment of PAD.”
Vaqar Ali, vice president and catheter lab director at First Coast Cardiovascular Institute in Jacksonville, USA, enrolled and treated the trial’s first patient.
“Our patient had a challenging SFA lesion that was treated thanks to the radial strength and flexibility afforded by the robust design of the TORUS stent graft,” Ali says. “We are thrilled to be the first site to enrol in this important trial and to be part of bringing this technology forward as a potential option for our patients.”
PQ Bypass general manager Heather Simonsen called the enrollment of the first patient “a significant milestone for PQ Bypass as we initiate our second pivotal IDE evaluating our unique technology in two different applications for patients with PAD. We are thrilled to commence TORUS 2, continue enrollment in DETOUR 2, and look forward to working with our investigators to execute two efficient and rigorous pivotal trials.”