HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding

Technical Success of Embolarization

Technical success is defined as absence of angiographic evidence of bleeding from the target location at completion of the index embolization procedure. Assessment performed on a per-lesion basis.

Time frame: Immediately after completion of the index procedure

Clinical Success at 7 Days

Clinical success defined as absence of bleeding from the target location after embolization without need for re-embolization or other re-interventions due to persistent or recurrent hemorrhage.

Time frame: 7 ± 2 days after embolarization

Clinical Success at 3 Months (Optional Follow-up)

Clinical success as defined for the primary endpoint, assessed at optional long-term follow-up.

Time frame: 90 ± 15 days after embolization

Successful Device Delivery

Successful delivery is defined as administration of Histoacryl® with intact microcatheter retrieval at the end of the embolization procedure.

Time frame: During the index embolization procedure

Immediate Clinical Improvement

Immediate clinical improvement is achieved when at least one unstable baseline parameter (systolic blood pressure, respiratory rate, Glasgow Coma Scale, or diuresis when applicable) improves to a stable level and none deteriorates to an unstable level after the embolization procedure. Definition of Glasgow Scale (GCS): is a clinical diagnostic tool widely used since the 1970s to assess a patient's level of consciousness. Initially primarily utilized in patients with traumatic brain injuries, its utilization has extended to assess the level of consciousness. The GCS score takes into consideration three components: eye movements, verbal response (e.g., speech), and motor response (e.g. purposeful body movements).