Alucent’s natural vascular scaffolding to be evaluated in ACTIVATE II FIH trial
Alucent Biomedical Inc. announced that it has enrolled the first patient in ACTIVATE II, an Australia-based first-in-human clinical trial to evaluate the safety and efficacy of AlucentNVS, the company’s natural vascular scaffolding device.
According to the company, the ACTIVATE II trial will enroll up to 50 patients at up to 12 research sites. The first patient in the ACTIVATE II study was enrolled by Chris Delaney, MD, at Flinders Medical Center in Adelaide, Australia. Other study sites will include Prince of Wales Hospital in Sydney, Australia; The Alfred Hospital in Melbourne, Australia; and Royal Perth Hospital and Sir Charles Gairdner Hospital in Perth, Australia.
The primary endpoints of the study are freedom
from composite investigational-device procedure- related major adverse events, primary patency as assessed by Doppler ultrasound, and freedom from clinically driven target lesion revascularization at 1 year.
The company noted that ACTIVATE II comes after the completion of enrollment for the ACTIVATE I safety study of AlucentNVS within the United States. Preclinical testing of AlucentNVS in animal studies has shown acute and long-term safety and patency without the proinflammatory and mechanical risks of placing a rigid foreign implant into the blood vessel.
Alucent Biomedical stated that the intervention is designed to deliver restoration of the vessel’s lumen and sustained improvement of blood flow without the
introduction of a foreign implant, such as a metallic stent. Absent a rigid foreign material, the arterial wall has the potential to retain its natural functionality and flexibility while avoiding traditional complications of permanent stents.
AlucentNVS photoactivated linking is also designed to mitigate the adverse effects of angioplasty, such as vessel recoil. Sustained improved blood flow is expected to result in pain relief, limb preservation, and improved quality of life for patients, advised the