ARTISAN: A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach with Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients with Pulmonary Arterial Hypertension

Subjects who meet all of the following criteria may be included in the study:

1. Voluntarily gives informed consent to participate in the study.
2. Males and females 18 years of age and above at the time of informed consent
   • Females of childbearing potential (defined as less than 1 year postmenopausal and not surgically sterile) must not be pregnant, lactating or planning to become pregnant while in the study or for 48 hours after discontinuing study drug. Subjects must have negative pregnancy tests at screening (serum) and baseline (urine prior to the RHC)
   • Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing the study drug.
3. Confirmed PAH (WHO Group 1) classified by one of the following subgroups:
   • Idiopathic, heritable or drug/toxin-induced (with the exception of amphetamine-induced PAH)
   • Associated with repaired congenital systemic-to pulmonary shunts (repaired ≥1 year)
   • Associated with connective tissue disease
   • Associated with human immunodeficiency virus infection
4. Baseline visit RHC must also meet the following criteria:
   • mPAP > 35mmHg
   • PVR≥3 Wood units
   • PAWP ≤15 mmHg
5. Treatment naïve or on a stable dose of an ERA and /or PDE-5i for ≥30 days, but <6 months prior to the baseline visit
6. REVEAL Lite 2 risk score ≤9
7. WHO FC II or III
8. 6MWD>165 m

1. Prior or current use of epoprostenol, treprostinil, iloprost, beraprost or selexipag
2. Positive vasoreactivity test in idiopathic, heritable, or drug/toxin induced PAH
3. Amphetamine use within the past 12 months
4. WHO Groups 2, 3, 4 and 5
5. Major Cardiovascular even (eg, myocardial infarction, stroke) within 2 months of screening
6. Systolic blood pressure <90 or >160 mmHg
7. Alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal during screening
8. Life expectancy less than 12 months
9. Use of any other investigational drug, device, or therapy within 30 days of the baseline visit
10. Moderate or severe hepatic impairment (Child-Pugh class B and C)
11. Any other clinically significant illness or abnormal laboratory value(s) measure during screening that, in the opinion of the investigator, might adversely affect interpretation of the study data or subject safety (e.g., active infection, chronic thromboembolic PH or acute/recent deep vein thrombosis or pulmonary embolism)