Barcelona Clinical Coordinating Center (BCCC), the non-profit contract research organization responsible for clinical coordination and patient recruitment, announces the completion of enrollment in the OPAL study, a first-in-human and pivotal clinical study evaluating the novel embolic liquid system Amber, sponsored by iVascular, a company developing innovative advanced medical devices and therapies for the treatment of disorders of the cardiovascular system.
The OPAL trial’s primary objective in the first-in-human phase is to assess the safety of Amber as an embolic liquid for peripheral complete vascular occlusion by evaluating the rate of serious device-related peri-procedural adverse events at 24 hours, adjudicated by an independent clinical events committee, while the pivotal phase aims to determine both the efficacy and safety of Amber by assessing the rate of complete vascular occlusion confirmed by angiography at the end of the procedure and the rate of serious device-related adverse events at 30 days post-embolization, also adjudicated by an independent clinical events committee. Recruitment was completed with the inclusion of 70 patients, in accordance with the study protocol, across 11 specialized centers in Spain. Completion of recruitment represents a key milestone and highlights the strong collaboration among participating investigators, clinical sites, and study teams.
OPAL is a prospective, single-arm, multicenter study designed to assess the safety and efficacy of the embolic liquid system Amber in patients requiring peripheral embolization. The study includes a broad range of indications, such as vascular malformations, hemorrhages, aneurysms, pseudoaneurysms, type II endoleaks, varicose veins, portal vein interventions, hypervascular tumors, and pathological organs. The study is led by Dr. Fernando Gómez from Hospital Universitari i Politècnic La Fe (Valencia, Spain).
“The timely completion of patient recruitment in this first-in-human study marks an important clinical milestone and highlights the team commitment supporting BCCC’s high-quality clinical program execution”, said Xavier Luria, Executive Director of Barcelona Clinical Coordinating Center.
About Barcelona Clinical Coordinating Center (BCCC)
Barcelona Clinical Coordinating Center is a non-profit CRO specializing in the coordination and management of clinical research projects, providing expertise in trial design, site management, data coordination, as well as regulatory and statistical support.
About iVascular
iVascular is a vertically integrated European medical device company specialized in the development and manufacturing of advanced solutions for vascular disease treatment, driven by innovation and clinical impact.
