W. L. Gore & Associates announced positive results from a prospective, multicenter Investigational Device Exemption (IDE) Clinical Study of the Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface in Japan.
The device demonstrated excellent outcomes in treating long, complex lesions in the superficial femoral artery (SFA), achieving 88 percent primary patency at 12 months.
The findings were presented during a Gore MEDICAL MASTERY Series event hosted in conjunction with the Vascular Interventional Advances 2016 (VIVA) Conference in Las Vegas.
The prospective single-arm study enrolled 103 patients for analysis across 15 trial sites. The trial enrolled a challenging patient population with greater than 10cm long lesions, including 84.5 percent TASC II C/D lesions, and 65.7 percent of lesions having chronic total occlusions (CTO).
The GORE VIABAHN Endoprosthesis showed favorable outcomes consistent with previous clinical studies. Primary patency at 12 months in all lesions (average of 21.8 cm) was 88 percent, while lesions less than or equal to 20 cm recorded 93 percent primary patency.
The study also demonstrated 100 percent limb salvage with zero cases of acute limb ischemia (ALI), bypass or amputation.
“Eighty-eight percent is an extremely high primary patency for these long complex lesions with an average length of 22 cm, especially given the scrutiny of the study design: a prospective, multicenter IDE clinical study that was core lab adjudicated and reviewed by the Japanese regulatory authority.
“The GORE VIABAHN Endoprosthesis, for the first time in endovascular history, may replace bypass surgery for femoro-popliteal disease,” said Takao Ohki, MD, Principal Investigator of the Gore Japan IDE Clinical Study.
The GORE VIABAHN Endoprosthesis is backed by a growing body of clinical data proving its safety and efficacy in challenging, real-world SFA lesions. The Gore Japan IDE Clinical Study is now the fourth prospective, multicenter trial to study performance of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in complex de novo and restenotic SFA disease.
When all figures and data from the research are combined, the 359 limbs studied in these four trials have an average lesion length of 21 cm with 71 percent CTO. The combined 12-month primary patency seen in the Gore VIPER Clinical Study, VIASTAR Trial, the GORE VIABAHN Device 25 cm Trial, and the Gore Japan IDE Clinical Study is 78 percent.
“The GORE VIABAHN Endoprosthesis has an extremely strong, growing body of clinical data in this category of complex SFA lesions,” said Ray Swinney, Business Unit Leader for the Gore Peripheral Interventional Business Unit.
“The Gore Japan IDE Clinical Study has once again proven that the VIABAHN device effectively covers and seals off diseased tissue, enabling high patencies regardless of lesion length. This clinical study demonstrates that endoluminal bypass continues to be an essential component of a physician’s toolkit for treating complex SFA disease.”