Table 2.

Safety and performance parameters

Assessment	Purpose	Follow-up timepoints	Evaluator
Angiography	To assess vessel patency	Baseline, procedure, and sacrifice (90 days)	Independent board-certified radiologist
Animal health	To assess animal health for any clinically significant observations	Monitored throughout the study duration through sacrifice (90 days)	Independent board-certified veterinarian
Clinical pathology (bloodwork)	To assess hematology and serum chemistry values related to animal health, including: • Liver • Pancreas • Kidney function	Pre-treatment, intermediate time point (30 days) and at sacrifice (90 days)	Independent board-certified veterinarian
Gross pathology (necropsy)	To assess any gross abnormalities, including: • Hepatic parenchyma of all liver lobes • Head, body, and tail of the pancreas • Proximal duodenum • Gall bladder • Kidneys • Small bowel • Psoas muscle adjacent to the renal arteries	At sacrifice (90 days)	Independent board-certified veterinary pathologist
Histopathology of the treatment area (renal arteries, common hepatic artery and surrounding tissues)	To assess: • Morphologic characterization of treatment area, including depth and circumferentiality • Vessel wall injury • Perivascular injury	At sacrifice (90 days)	Independent board-certified veterinary pathologist
Norepinephrine assessment	To assess denervation of the liver, kidneys and adjacent organs (pancreas and duodenum)	At sacrifice (90 days)	Independent test laboratory