Endologix recently announced the 12-month results of the DETOUR-2 trial at the 2022 VIVA Vascular InterVentional Advances (VIVA) Conference in Las Vegas.
“DETOUR-2 showed promising results in both safety and efficacy among patients treated with endovascular approach for long complex SFA/POP occlusions including severe calcification, in stent restenosis, and long occlusions,” said Jihad Mustapha MD, FACC, FSCAI, co-principal investigator for the DETOUR 2 trial, president and CEO and Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention, in prepared remarks.
Mustapha continued by saying that the recently presented data are extremely encouraging and that the DETOUR procedure will provide a new treatment modality for many patients who may not be candidates for surgical or native endovascular revascularizations.
DETOUR-2 was designed to evaluate safety and effectiveness of the DETOUR System for percutaneous bypass in the treatment of long-segment femoropopliteal disease. The DETOUR System, which earned FDA’s Breakthrough Device Designation, is comprised of Endologix’s ENDOCROSS Device and TORUS stent graft.
The study’s primary safety endpoint is a composite outcome of major adverse events (MAE) through 30 days, and consists of death, CD-TLR, amputation of the target limb, symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), and the need for transfusion of packed red blood cells (PBRC) at the index procedure.
One of the study’s principal investigators, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute presented the following results at the VIVA conference. Ninety-six percent of enrolled patients had chronic total occlusions, with a mean lesion length of 32.7cm and technical success was achieved in 100% of treated patients. The primary safety endpoint was surpassed, with a 30-day MAE rate of 7.0%. The 1-year effectiveness endpoint was also met, with 72.1% freedom from CD-TLR and recurrent stenosis > 50% at 12 months. The primary assisted patency was 77.7% at 12 months. The secondary patency at 12 months was 89%.
Patient quality of life was also markedly improved, as measured by the EQ-5D-5L index, when comparing pre-and post-treatment scores. Mean index values of 0.69, 0.77, and 0.80, were seen at baseline, 30 days, and 12 months respectively. Mean EQ VAS scores were 62.8, 72.1, and 70.5 during the same time.
“The presentation of this study represents an important milestone in our effort to bring this novel therapy to market, as we seek U.S. regulatory approval to offer endovascular alternatives to open lower limb bypass for patients with long femoropopliteal occlusions,” said Matt Thompson, President and CEO of Endologix, in a company statement.
The clinical trial has enrolled 202 patients in the United States and Europe for the primary analyses. A PMA Application for the DETOUR Systems was submitted to FDA in October 2022.