HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding

Clinical success is defined as absence of bleeding from the target location after embolization with Histoacryl® without need for re-embolization or other re-interventions of the target lesion due to persistent or recurrent hemorrhage. Assessment performed on a per-patient basis.

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.

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.

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

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

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).

Proportion of patients without serious adverse events following embolization.

Occurrence of major relevant procedure-related complications including non-target embolization, allergic reaction, and catheter breakage or entrapment.

Occurrence of ischemic complications in the target location following embolization.

Occurrence of serious adverse events considered related to Histoacryl®

Death from any cause following embolization treatment.

Death attributable to the target location bleeding event.

Need for surgical intervention because of persistent or recurrent bleeding not controlled by embolization.

Duration of hospitalization following the embolization procedure.

Occurrence of rehospitalization that was not planned at the time of discharge.