PQ Bypass, a company developing a fully percutaneous bypass treatment for patients with long, complex superficial femoral artery (SFA) occlusions—TransAtlantic InterSociety (TASC) II D—announced that the DETOUR I trial has met its primary safety and efficacy endpoints.
 
Treatment options to revascularize extremely long arterial blockages in the leg due to peripheral artery disease have traditionally required open surgical bypass for long-term success. More recently, standard endovascular techniques and technologies have emerged; however, a better solution is still needed as these less invasive techniques do not provide reliable, long-term outcomes for this type of complex lesion.
 
With an increased focus on value-based and patient-centered medicine, surgical advancements that minimize trauma to patients, reduce length of hospital stay and recovery times, are critical global needs. With these goals in mind, PQ Bypass has developed an entirely new technique for treating extremely long SFA blockages. The novel 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, multi-center, 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 compelling safety and performance data with both primary safety and effectiveness endpoints having been met. Key results include:
 

• Primary safety endpoint: 30-day major adverse event (MAE) rate—3.4 percent
   - MAE defined as death, target vessel revascularization and target limb amputation
• Primary efficacy endpoint: 6-month primary patency rate—84.7 percent
   - Result = 15 percent higher than study performance goal of 70 percent
• High procedural and technical success rates of 96.7 and 98.3 percent, respectively
• Venous health was maintained at six months with no change on venous function scores as measured by Villalta and VCSS scales
• Exactly 94.7 percent of subjects achieved endpoint of ≥1 improvement on Rutherford Becker Clinical Category class at six months as compared to baseline (p<0.0001)
  - The majority of patients (91.2 percent) improved by 2 or 3 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 revascularization via modular stent graft bypass, a much-needed treatment option for patients with long-segment occlusive disease,” said Prof. Dierk Scheinert, M.D., chairman of the Division of Interventional Angiology at University Hospital Leipzig in Germany. “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 SFA 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 percent of the lesions treated characterized as chronic total occlusion (CTO) and 93 percent as TASC II D. Mean age was 64 years, 83.3 percent of patients were male, and 33.3 percent of the population had previous peripheral artery revascularization or surgery.
 
“We are thrilled with the 6-month data from DETOUR I,” said Peter Wehrly, president and CEO of PQ Bypass. “We view the DETOUR procedure as a transformative step forward in how physicians treat long-segment SFA disease. We believe our percutaneous approach will demonstrate the durable patency outcomes previously only seen with open bypass surgery, and steer care away from costly intraluminal endovascular techniques that are arduous and lack sufficient durability.”
 
During the PQ DETOUR procedure, fluoroscopic guidance is used to deploy a series of PQ Bypass stent grafts from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery (SFA) in a continuous, overlapping fashion through two independent anastomoses. The final result is a large lumen, endograft bypass that delivers unobstructed, pulsatile flow from the SFA ostium to the popliteal artery and restores blood flow to the lower extremities.
 
PQ Bypass Inc. is a Silicon Valley-based medical device company working to transform the treatment of long-segment peripheral artery disease with minimally-invasive endovascular solutions. Its executive team members have held senior leadership positions at companies including Medtronic plc, Abbott, Johnson & Johnson, Covidien plc, and Stryker Corp., and also have experience developing medical devices for startups such as Evalve, AccessClosure, Altura, Avinger, and DVI.
 
The underlying technology and technique used in the percutaneous PQ DETOUR procedure were co-developed by two cardiologists and innovators, Dr. James Joye and Dr. Richard Heuser, who are recognized experts in peripheral artery disease. The PQ Bypass technology platform is not available for sale and is currently undergoing clinical trials.