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. 2023 Mar 20;18(15):1227–1243. doi: 10.4244/EIJ-D-22-00723

Table 2. Ongoing sham-controlled RCTs (as of June 2022).

Trial, NCT* Catheter system Design, (randomisation ratio) Sample size Inclusion criteria Primary efficacy outcome Estimated trial completion
SPYRAL HTN-ON MED Expansion, NCT02439775 Symplicity Spyral (multi-electrode RF) Bayesian adaptive design, RDN vs sham (1:1) 340 Uncontrolled office and 24-hour BP on 1-3 antihypertensive drugs Change in 24-hour SBP at 6 months 2026
RADIANCE II, NCT03614260 Paradise (US) RDN vs sham (1:1) 225 Uncontrolled stage II hypertension (office and daytime ambulatory BP) in absence of antihypertensive drugs Change in daytime ambulatory SBP at 2 months 2022
TARGET BP OFF-MED, NCT03503773 Peregrine (ethanol injection via microneedles) RDN vs sham (1:1) 90 Uncontrolled office and 24-hour BP in absence of antihypertensive drugs Change in 24-hour ambulatory SBP at 2 months 2023
TARGET BP I, NCT02910414 Peregrine (ethanol injection via microneedles) RDN vs sham (1:1) 300 Uncontrolled office and 24-hour BP on 2-5 antihypertensive drugs Change in ambulatory 24-hour SBP at 3 months 2025
*NCTs found at ClinicalTrials.gov. BP: blood pressure; RDN: renal denervation; RF: radiofrequency; SBP: systolic blood pressure; US: ultrasound