January 24, 2017
PQ Bypass Announces DETOUR I Study Results
January 24, 2017—PQ Bypass, which is developing a fully percutaneous bypass treatment for patients with long, complex superficial femoral artery (SFA) occlusions, announced that the DETOUR I trial has met its primary safety and efficacy endpoints. Professor Dierk Scheinert, MD, presented the data at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.
According to the company, the PQ Detour procedure is designed to match or exceed the durable patency associated with open surgical bypass, but results are achieved with a minimally invasive endovascular procedure that allows rapid return to full function.
DETOUR I is a prospective, multicenter, independently reviewed single-arm trial designed to evaluate the safety and efficacy of the PQ Detour procedure in patients with long-segment TASC II D occlusive disease in the femoropopliteal anatomy.
The trial was conducted at seven international sites and enrolled 60 patients. Fifty-nine patients received treatment. The average lesion length was 28.6 cm, with 95% of treated lesions characterized as chronic total occlusions and 93% considered TASC II D lesions. Mean age was 64 years, 83.3% of patients were men, and 33.3% of the population had previous peripheral artery revascularization or surgery.
As reported at LINC, DETOUR I met both primary safety and effectiveness endpoints, with 6-month safety and performance results as follows:
- The 30-day major adverse event (MAE) rate (the primary safety endpoint) was 3.4%. MAE was defined as death, target vessel revascularization, and target limb amputation.
- The 6-month primary patency rate (the primary effiacy endpoint) was 84.7%, which is 15% higher than the study performance goal of 70%.
- Procedural and technical success rates were 96.7% and 98.3%, respectively.
- Venous health was maintained at 6 months with no change in venous function scores as measured by Villalta and Venous Clinical Severity Score scales.
- The endpoint of ≥ 1 improvement on Rutherford class at 6 months as compared with baseline was achieved in 94.7% of patients (P < .0001). In addition, 91.2% improved by two or three Rutherford classes at 6 months compared with baseline.
In the company's press release, Prof. Scheinert commented, "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."
He continued, "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.” Prof. Scheinert is Chairman of the Division of Interventional Angiology at University Hospital Leipzig.
The company explained that the PQ Detour procedure uses fluoroscopic guidance to deploy a series of PQ Bypass stent grafts from the popliteal artery into the femoral vein and from the femoral vein into the SFA in a continuous, overlapping fashion through two independent anastomoses. The 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.
The PQ Bypass technology platform is not available for sale and is currently undergoing clinical trials, advised the company.