PQ Bypass’ DETOUR I clinical trial has showed safety and effectiveness of the DETOUR system in the treatment of long-segment (>25 cm) blockages in the femoropopliteal artery
The data were presented as a late breaking clinical trial session today at Vascular InterVentional Advances (VIVA 17) by Dr. Sean Lyden, chairman of the department of Vascular Surgery at Cleveland Clinic.
In complex peripheral artery disease (PAD), arteries in the leg can become blocked by long segments of plaque that restrict blood flow to the lower leg and foot. This can lead to pain, loss of mobility and amputation.
Extremely long blockages, such as those greater than 20 centimeters, are quite challenging to treat. Historically, physicians have treated these blockages with open bypass surgery, which has the benefit of durability; however, it is associated with an increased risk of complications, longer hospital stays and prolonged rehabilitation.
Minimally invasive approaches to PAD, including angioplasty and stenting, work very well on shorter blockages; however, they have not been as effective on longer ones.
“Patients with long segment femoropopliteal blockages are in need of advanced therapeutic alternatives to existing treatments. While endovascular revascularization is effective in shorter lesions, its durability in longer segment blockages has not matched that of open surgery. Fully percutaneous bypass is designed to combine the durability advantages of surgical bypass with the minimally invasive advantages of a percutaneous procedure,” said Dr. Lyden.
“The outcomes we are seeing in the DETOUR I trial indicate that a fully percutaneous bypass procedure has potential to fill this gap in treatment options.”
The analysis of a subset of the DETOUR I study presented today at VIVA 17 is one of the largest prospective series ever to evaluate the percutaneous treatment of femoropopliteal blockages with lengths of 25 cm to 45 cm (mean of 33.8 cm).
The six-month outcomes from 50 patients demonstrated the DETOUR System’s ability to successfully treat these long blockages without significant impact on venous health and low rates of major adverse events (MAEs). The results included:
Primary safety endpoint: 2 percent MAEs – defined as death, target vessel revascularization (TVR) or amputation at 30 days. There were no deaths or amputations and one TVR.1
Primary patency of 88.9 percent at six months with optimal placement; overall primary patency of 76.9 percent
Successful delivery of devices to the identified area and removal of the delivery system in 100 percent of lesions (53/53)
Improvement in Rutherford Class of at least 2 grades in 92 percent of patients (45/49)2
Significant improvement in ankle brachial index from 0.64 ± 0.17 to 0.92 ± 0.14 (p<0.0001)
No impact on venous function; no device-related deep vein thrombosis in treated vessels
Percutaneous femoropopliteal bypass (the DETOUR procedure) is a newly developed procedure that utilizes PQ Bypass’ proprietary DETOUR System technologies – TORUS Stent Graft, DETOUR Crossing Device and DETOUR Snare – to provide fully percutaneous bypass of long-segment blockages in the femoropopliteal artery.
The DETOUR procedure creates a pathway around a lesion by placing stent grafts that cross from the superficial femoral artery (SFA) into the femoral vein and back into the artery. The new path through the stent grafts re-directs oxygen-rich blood around the blockage and restores blood flow to the lower leg and foot of the patient.
“PQ Bypass has long been committed to addressing the need for value-based, patient-centered advancements in PAD that help minimize trauma, reduce length of stay and improve recovery times, while also providing a safe and effective clinical solution for these patients who are in need,” said Richard Ferrari, PQ Bypass’ chairman of the board.
“These data demonstrate the potential of the DETOUR procedure in extremely long SFA lesions. We look forward to continuing our path toward regulatory approval with DETOUR II, a pivotal trial that we anticipate initiating by the end of this year.”
In March 2017, PQ Bypass received CE (Conformité Européenne) Mark approval for all three devices that are included in the DETOUR System.
VIVA 17 is the premier global, multidisciplinary course for vascular intervention and medicine, providing excellence in professional education for all specialties and stakeholders who treat the vascular patient.