(Leipzig, Germany) January 30, 2020 -- Peter A Schneider, MD, a vascular surgeon within the Division of Vascular and Endovascular Surgery at the University of California, San Francisco, presented an important ongoing trial of the DETOUR System (PQ Bypass, Inc.) for femoropopliteal bypass. “I’ve been involved in a number of different methods to tackle femoropopliteal lesions and one of them is the DETOUR System,” Dr Schneider said. “I think it has the potential to be the next generation for bypass.”
The DETOUR System, under fluoroscopic guidance, deploys a series of 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.1 The intended result is a large lumen, endograft bypass that delivers unobstructed, pulsatile flow from the SFA ostium to the popliteal artery.1
Important to realize, added Dr Schneider, is that the PQ Bypass system does not compete with endovascular solutions: “This is not just another endovascular procedure – you are going after lesions that have never been considered for endovascular treatment before. It’s competing with femoropopliteal bypass – which is an important aspect of open vascular surgery.”
Dr Schneider discussed the latest investigational device exemption (IDE) study of the DETOUR System, dubbed the US IDE DETOUR II Clinical Trial, which is currently recruiting across 37 sites in the U.S., Germany, Poland, and Latvia. As is standard for IDE trials, the study is bound by strict guidelines, including the minimum number of patients to be included. The primary endpoint is patency at one year. Secondary endpoints are focused on follow-up for deep vein integrity, noted Dr Schneider. “It’s making nice progress,” he said, relaying that more than half of the enrollment is now complete.
Importantly, what makes this trial an exception is that the average lesion length is 35 to 40 cm. “In that sense, this is dramatically different from other types of endovascular procedures where the lesions are typically much shorter. This has never been undertaken previously with any kind of endovascular procedure. You can see why this is a special trial.”
Importantly, many different specialties have embraced the DETOUR procedure, added Dr Schneider. “It’s not just vascular surgeons, it’s also interventional cardiologists, interventional radiologists, and angiologists.”
Having several specialties involved hastens the evolution and refinement of the procedure, continued Dr Schneider: “Procedures get to the right patients a little quicker if there are multiple specialties collaborating on the development of it. I think that’s the case here, which is a good thing.
“Whenever we have a new procedure, we have a developmental timeframe during which we can really get used to the practice. This being a multistep procedure, it took a little time, but now it’s routine for these cases to be done in two hours or less.” That duration competes favorably with open bypass patients, noted Dr Schneider, with patients typically being treated as outpatients.
Grzegorz Halena from the Medical University of Gdansk (Poland) and Dainis Krievins from the Pauls Stradins Clinical University Hospital, the University of Latvia (Riga, Latvia) were instrumental in developing this procedure, Dr Schneider went on: “They found out what works, what was most expeditious and what needs to be done to make it successful. They have both been terrific to really push this forward from a clinical standpoint.”
Should the device be FDA approved, Dr Schneider foresees a change in the way bypasses are approached worldwide. “There’s still a substantial number of lower extremity surgical bypasses done in the United States, as well as in other countries, and I think that those numbers will decrease because some of those patients will go on and have a bypass with the DETOUR System,” he said. “I can picture a situation where DETOUR could be good enough to really replace open bypass in a lot of patients, or it could be used in patients that need a fem-pop bypass, but just can’t because of other risk factors.”
Certainly there may be a new set of patients who could receive the DETOUR System that would not previously have qualified for open surgery. That includes the kind of critical inpatient who may have been put forward for amputation because an open bypass would be too risky. So, on the one hand it could potentially compete directly with the established procedure, but on the other hand, it may broaden the scope of patients who may be treated because in the past, for a 35 or 40 cm lesion, there would be limited options, said Dr Schneider.
Other patient groups might also see additional benefits from DETOUR II, he noted. As an IDE study, it’s directed towards claudication, but the procedure may also be of benefit to critical limb ischaemia patients, he added.
“This is a procedure that’s really extending what we can do with endovascular therapies. DETOUR II is taking on longer lesions than have ever been approached by endovascular means,” concluded Dr Schneider.