Positive safety and efficacy results from PQ Bypass DETOUR I study presented at LINC 2017

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PQ Bypass has announced that the DETOUR I trial has met its primary safety and efficacy endpoints.
The data were presented by Dierk Scheinert, chairman, Division of Interventional Angiology,
University Hospital Leipzig, Germany at the 2017 Leipzig Interventional Course (LINC; 24-27 January,
Leipzig, Germany).

With an increased focus on value-based and patient-centred medicine, surgical advancements that
minimise trauma to patients, reduce length of hospital stay and recovery times, are critical global
needs. With these goals in mind, PQ Bypass has developed a new technique for treating extremely
long superficial femoral artery blockages. The PQ Detour procedure is designed to match or exceed
the durable patency associated with open surgical bypass, but achieve those results with a minimally
invasive endovascular procedure that allows rapid return to full function.

DETOUR I is a prospective, multicentre, independently-reviewed single-arm trial designed to
evaluate the safety and efficacy of the PQ Detour procedure in patients with long-segment
TransAtlantic InterSociety (TASC) II D occlusive disease in the femoral-popliteal anatomy. The six-
month results from DETOUR I demonstrate that both primary safety and effectiveness endpoints
have been met. Key results include:

  • Primary safety endpoint: 30-day major adverse event rate of 3.4%, where major adverse
    event is defined as death, target vessel revascularization and target limb amputation
  • Primary efficacy endpoint: six-month primary patency rate of 84.7%, which is a result of
    almost 15% higher than study performance goal of 70%
  • High procedural and technical success rates of 96.7% and 98.3% respectively
  • Venous health maintained at six months with no change on venous function scores as
    measured by Villalta and VCSS scales
  • 94.7% of subjects achieved endpoint of >1 improvement on Rutherford Becker Clinical
    Category class at six months as compared to baseline (p<0.0001)
  • Majority of patients (91.2%) improved by two or three Rutherford Classes at six months as
    compared to baseline“The data from this study strongly suggest that the PQ DETOUR procedure provides a viable option
    for revascularisation via modular stent graft bypass, a much-needed treatment option for patients
    with long-segment occlusive disease,” says Scheinert. “The clinical performance in severe lesions
    demonstrates the potential for this novel therapy for complex patients who are otherwise left
    without a durable endovascular option. The results warrant further evaluation as percutaneous
    bypass using the femoral vein as a conduit may prove to be an important step forward in the
    treatment of extremely long superficial femoral artery occlusions.”

    Conducted at seven sites internationally, DETOUR I enrolled 60 patients and 59 received treatment.
    The average lesion length was 28.6 cm, with 95% of the lesions treated characterised as chronic total
    occlusion (CTO) and 93% as TASC II D. Mean age was 64 years, 83.3% of patients were male, and
    33.3% of the population had previous peripheral artery revascularisation or surgery.