Vancouver-based Neovasc said the clinical protocol for its COSIRA (coronary sinus reducer for treatment of refractory angina) trial has been published in the peer-reviewed journal Trials. COSIRA is a double-blind, randomized, multi-center trial further assessing the efficacy and safety of the Neovasc Reducer, a novel percutaneous device for the treatment of refractory angina. The COSIRA trial is currently enrolling patients in the U.K., Europe and Canada.
"COSIRA was designed as a rigorous, sham-controlled study to provide definitive evidence of the efficacy of the Reducer device, and we are pleased that the protocol is being recognized as noteworthy by the clinical research community," said Shmuel Banai, M.D., chief medical officer of Neovasc. "We are on target for completion of patient enrollment in the second quarter of 2013, with six-month follow-up data from all patients expected to be available around year's end."
The Reducer has received a CE mark designation in Europe for treatment of refractory angina. Neovasc is also following Reducer patients in two open-label Registries being conducted in Europe and Israel.
Neovasc CEO Alexei Marko said, "Patient outcome data from our pilot studies and Registry patients enrolled to date has been very promising, and we look forward to reporting the results of the COSIRA study in the coming months."