PQ Bypass, Inc. reports the study will enroll up to 292 patients at up to 40 centers in the U.S. and Europe with patient follow-up out to 36 months. The trial also includes a prospective economic study to collect quality-of-life outcome measures and cost data, including rehospitalizations.
Vasili Lendel, M.D. and André Paixao, M.D. initiated the DETOUR II trial in the U.S. at Arkansas Heart Hospital in Little Rock today, enrolling two patients with complete blockages in the SFA longer than 30 centimeters.
Sean P. Lyden, M.D., professor and chairman of the department of vascular surgery, Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic, and national co-principal investigator of the trial said, “We are excited to start treating patients in the DETOUR II IDE trial, studying a procedure that may improve upon existing treatment options for patients with long-segment femoropopliteal disease.” Lyden added, “The DETOUR II trial is designed to provide definitive safety and effectiveness data on the new percutaneous bypass procedure, which has the potential to provide the effectiveness of open surgery through a minimally-invasive endovascular approach for these challenging lesions.”
Enabled by PQ Bypass’ patented DETOUR™ System, the DETOUR procedure creates an endovascular bypass, using proprietary stent grafts, that originates in the SFA, travels through the femoral vein, then returns into the popliteal artery. This new pathway is designed to re-direct oxygen-rich blood around the diseased part of the vessel, restoring blood flow to the lower leg and foot of the patient.
“DETOUR is an innovative, yet intuitive endovascular procedure to create a bypass in a channel already provided by the body, but without performing open surgery,” said Jihad Mustapha, M.D., CEO of Advanced Cardiac and Vascular Amputation Prevention Centers, clinical associate professor of medicine at Michigan State University College of Osteopathic Medicine, and national co-PI of the DETOUR II study. “We look forward to working with the trial sites and, ultimately, to seeing the results from this landmark study.”
The lack of an optimal treatment alternative for long-segment femoropopliteal occlusions is a persistent issue for patients with advanced PAD. Published literature has demonstrated that conventional endovascular approaches result in at least 30 to 40 percent lower patency in these blockages when compared to the same treatments used for shorter lesions1,2. Studies have also shown that these patients could experience a 40 percent rate of re-treatment within 12 months3.
“The enrollment of the first U.S. patients in our pivotal DETOUR II trial is an important milestone, not only for PQ Bypass, but for the physician and patient communities who will benefit from the evolution of treatment alternatives for advanced PAD,” said Heather Simonsen, vice president of therapy development for PQ Bypass. “We look forward to confirming that the novel DETOUR System and procedure offer a compelling alternative for patients with complex femoro popliteal disease.”
The DETOUR™ System is an investigational device in the U.S.
1 Hong, Sung-Jin, Young-Guk Ko, Dong-Ho Shin, Jung-Sun Kim, Byeong-Keuk Kim, Donghoon Choi, Myeong-Ki Hong, and Yangsoo Jang. “Outcomes of spot stenting versus long stenting after intentional subintimal approach for long chronic total occlusions of the femoropopliteal artery.” JACC: Cardiovascular Interventions 8, no. 3 (2015): 472-480.
2 Taneja, Manish, K. H. Tay, M. Sebastian, S. Pasupathy, S. E. Lin, T. Teo, R. Low et al. “Self-expanding nitinol stents in recanalisation of long-length superficial femoral artery occlusions in patients with critical limb ischaemia.” Singapore Med J 50, no. 12 (2009): 1184-1188.
3 Baril, Donald, Rabih Chaer, Robert Y. Rhee, Michel S. Makaroun, Luke K. Marone. “Endovascular Interventions for TASC II D femoropopliteal lesions.” Journal Vascular Surgery 51, no. 6 (2010): 1406-1412
4 Overview of Classification Systems in Peripheral Artery Disease Semin Intervent Radiol 2014;31:378–388
5 Kasapis, Christos, and Hitinder S. Gurm. “Current approach to the diagnosis and treatment of femoral-popliteal arterial disease. A systematic review.” Current cardiology reviews 5, no. 4 (2009): 296-311.
6 Morbidity of Femoropopliteal Bypass Surgery. van de Weijer MA, Kruse RR, Schamp K, Zeebregts CJ, Reijnen MM Semin Vasc Surg. 2015 Jun; 28(2):112-21.