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August 5, 2024
Vascular Therapies’ ACCESS 2 Study of Sirogen Completes Enrollment
August 5, 2024—Vascular Therapies announced completion of enrollment in the ACCESS 2 trial of Sirogen, a sirolimus-eluting collagen implant that the company is developing for intraoperative local, perivascular drug delivery.
According to the company, the phase 3 prospective randomized, multicenter clinical study is evaluating Sirogen for the surgical creation of arteriovenous (AV) fistula in patients requiring hemodialysis vascular access.
The ACCESS 2 investigators enrolled 136 patients at 17 centers in the United States and the United Kingdom. The primary endpoint of the study is fistula maturation at 6 months, and results are currently expected to be announced in the second quarter of 2025. The initiation of enrollment in ACCESS 2 was announced in August 2022.
The company noted that in a post-hoc subgroup analysis from ACCESS, the original United States prospective randomized study, Sirogen demonstrated improved fistula maturation and secondary patency when compared to standard of care controls.
According to Vascular Therapies, 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.
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