Introduction Cerebral vasospasm (CV) is a devastating medical complication of aneurysmal subarachnoid hemorrhage (SAH). The current endovascular approach includes intra-arterial vasodilators and angioplasty.

Aim of Study We present interim data from a multi-center study evaluating the safety and effectiveness of angioplasty with the Comaneci device in treating symptomatic CVs.

Methods This is a single-arm, open, multi-center, prospective registry study. The primary outcome is a procedural success, defined as 50% or greater vessel caliber on DSA compared to baseline. The primary safety outcomes include intraoperative and post-treatment events. Radiological evaluation is based on a four-level scale. The study enrolled patients aged ≥18 years presenting with CV exceeding 50% following SAH, who were treated with the Comaneci device as a first-line endovascular treatment in the affected segments.

Results Ten (60% female, mean age 47.8) subjects from 5 different European sites were enrolled. Eighteen vessel segments were treated with Comaneci. Procedural success was achieved in 94% of treated segments. One intraoperative complication (worsening of vasospasm) was reported. Vasospasm recurrence was reported for 2 vessels (11%). The 30 days post-treatment mRS was decreased by one point in 4/6 (67%), unchanged in 1 and increased by one point in 1 subject, respectively. Data is still under monitoring process and imaging core lab review.

Conclusion The interim results of this study demonstrate a high rate of angiographic success with a minimal rate of complications and suggest a trend towards improved clinical outcomes. Comaneci may be a viable approach for safely treating vasospasm following aneurysmal SAH.

Disclosure of Interest no.