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b'BMI >40 kg/m2'
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b'Diagnosis of type 1 diabetes'
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b'Current or previous use of injectable diabetes medications (e.g., insulin and GLP-1RA)'
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b'Current use of >2 hypertension medications'
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b'Two or more self-reported or documented severe hypoglycemia events (severe'
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b'hypoglycemia event defined as: hypoglycemia associated with severe cognitive'
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b'impairment requiring external assistance for recovery) in the 180 days prior to Index'
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b'Procedure'
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b'One or more documented hyperglycemia episodes requiring hospitalization in the'
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b'180-days prior to Index Procedure'
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b'During medication run in period, uncontrolled hyperglycemia noted by a fasting glucose'
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b'value of >270mg/dL or >360mg/dL at any point that is then confirmed by a second'
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b'measurement (not on the same day)'
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b'A history of bariatric surgery, renal denervation, baroreflex activation therapy, or'
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b'liver transplant, or these procedures are planned in the 365 days following Index'
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b'Procedure'
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b'Any surgical procedure within 30 days prior to Index Procedure'
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b'History of gallstones without a cholecystectomy being performed or current gallstones'
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b'(Note: subjects who have had a cholecystectomy are not excluded)'
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b'Previous hepatobiliary surgery/intervention that in the opinion of the investigator'
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b'could preclude the ability to perform denervation of the common hepatic artery'
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b'Currently taking the following medications within 90 days prior to screening and/or'
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b'there is a need or anticipated need for these medications during the study:'
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b'Systemic Corticosteroids'
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b'Anticonvulsants'
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b'Centrally acting sympatholytics'
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b'Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14'
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b'days after the Index Procedure'
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b'Any other condition(s) that would compromise the safety of the Subject or compromise'
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b'tudy quality as judged by the Investigator'
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b'eGFR <60 mL/min/1.73 m2'
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b'History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy'
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b'(e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of'
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b'gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)'
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b'Unstable cardiovascular disease, myocardial infarction, unstable angina, widespread'
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b'atherosclerosis with documented intravascular thrombosis or unstable plaques'
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b'Documented history or concurrent signs of significant thyroid disease NOTE: If a'
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b'ubject is on chronic thyroid drug treatment, and has a serum TSH test result in'
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b'normal range at Baseline they may enter study'
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b'Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet'
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b'count <100,000/microliter, or documented coagulopathy'
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b'Significant alcohol consumption, defined as more than 2 drink units per day'
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b'(equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men,'
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b'or inability to reliably quantify alcohol intake'
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b'Active substance abuse, based on Investigator judgment, including inhaled or injected'
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b'drugs, within 1 year prior to the initial screening'
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b'Significant weight loss within the last 6 months (e.g., >10% total body weight loss)'
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b'Hepatic decompensation defined as the presence of any of the following:'
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b'Serum albumin less than 3.5 g/dL'
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b'International normalized ratio (INR) greater than 1.4 (unless due to therapeutic'
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b'anticoagulants)'
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b'Total bilirubin greater than 2 mg/dL with the exception of Gilbert syndrome'
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b'History of esophageal varices, ascites, or hepatic encephalopathy'
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b'ALT or AST greater than 200 U/L'
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b'Diagnosis of liver cirrhosis'
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b'Chronic liver or biliary disease of the following etiology:'
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b'History or diagnosis of Hepatitis B'
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b'History or diagnosis of Hepatitis C'
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b'History or diagnosis of current active autoimmune hepatitis'
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b'History or diagnosis of primary biliary cholangitis (PBC)'
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b'History or diagnosis of primary sclerosing cholangitis'
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b"History or diagnosis of Wilson's disease"
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b'History or diagnosis of alpha-1-antitrypsin deficiency'
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b'History or diagnosis of hemochromatosis'
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b'History or evidence of drug-induced liver disease, as defined on the basis of'
|
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b'typical exposure and history'
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b'Known bile duct obstruction'
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b'Suspected or proven liver cancer'
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b'History of acute or chronic pancreatitis'
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b'Subjects unable to undergo MRI-PDFF or CT for any reason'
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b'Currently enrolled in any other investigational trial'
|
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|
b'History of an acute neurologic event including epilepsy, seizures, stroke, and'
|
|
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b'transient ischemic attack.'
|
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|
b'Iliac/femoral artery stenosis precluding insertion of the catheter'
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|
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|
b'Human immunodeficiency virus (HIV)'
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|
|
b'Subjects with a history of adverse reaction to heparin or heparin induced'
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|
b'thrombocytopenia (HIT)'
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|
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|
b'Subjects with conditions that can affect RBC turnover, those who have received a blood'
|
|
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|
|
b'transfusion in the past 90 days, or expect to have an elective procedure during the'
|
|
|
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|
|
b'course of the study that may require blood transfusion'
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|
|
b'Not a candidate for surgery or general anesthesia'
|
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|
|
b'Unwilling to comply with study requirements, including medication run-in, SMBG,'
|
|
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|
|
b'patient diary and follow-up visits'
|
|
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|
|
b'Subjects with implantable pacemakers, implantable cardiac defibrillators or'
|
|
|
|
|
|
b'implantable neurostimulators Anatomic Exclusions from CT Angiogram'
|
|
|
|
|
|
b'Replaced or accessory LHA or RHA determined on CT angiogram.'
|
|
|
|
|
|
b'Vessel tortuosity or variant vascular anatomy that could preclude the access or'
|
|
|
|
|
|
b'maneuvering of the device from the femoral artery to the target location'
|
|
|
|
|
|
b'Evidence of CHA and/or portal vein intraluminal thrombus'
|
|
|
|
|
|
b'CHA vessel diameter <4.0mm or >7.0mm'
|
|
|
|
|
|
b'CHA diameter stenosis >30%'
|
|
|
|
|
|
b'CHA vessel length <20mm'
|
|
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|