Vascular Therapies has today announced completion of enrollment in the ACCESS 2 trial, a Phase III prospective randomized, multicenter clinical study of Sirogen for the surgical creation of arteriovenous (AV) fistula in patients requiring hemodialysis vascular access.
Vascular Therapies developed its sirolimus formulation (Sirogen) for intraoperative local, perivascular drug delivery. In a post-hoc subgroup analysis from ACCESS, the original US prospective randomized study, Sirogen showed improved fistula maturation and secondary patency when compared to standard of care controls.
The ACCESS 2 Study was designed to validate the post-hoc results from ACCESS and further evaluate the effectiveness of Sirogen to improve outcomes in patients requiring an AV fistula. This multicenter randomized study enrolled 136 patients across 17 centers in the U.S. and the United Kingdom. The primary endpoint of the study is fistula maturation at six months, and results are currently expected to be announced in the second quarter of 2025.
