All imaging and BP measurements to go through a central core lab. Sites will utilize their local labs for blood and urine samples with the exception of the urine concentration for antihypertensive medications which will go to the central lab: BioRep.

Neither SoniVie/Boston Scientific nor the screeners will need access to MCVI’s EMR. At the SIV we will be providing thorough training on the full process.

The social media campaign will include advertisements through social media sites such as Facebook and Instagram. Patients will be directed to a landing page to answer basic questions. Those who qualify based on those answers will be pushed through to a screener who will review the inclusion/exclusion criteria with them directly.

Only the screener (consultant and not an employee of SoniVie/Boston Scientific) will see the patient’s PHI. If the screener confirms that the patient is an ideal candidate, they will then provide them to the site closest to the patient. We, as the sponsor, will never have access or visibility to the patient questionnaires.

Patients are offered the chance to crossover if they remain uncontrolled at 6M follow-up once unblinded. The escape criteria can occur at any timepoint according to their office BP readings.

Yes, one blinded and one unblinded study coordinator. The unblinded coordinator would be needed at the procedure and would be expected to complete data entry for the procedure in order to maintain the blind for other site staff. Additional details will be provided at the SIV.

The website is a SoniVie/Boston Scientific built as part of our recruitment project branded as "PinPoint" for this study. The CRM (Customer Relationship Management) platform used to manage candidates coming from PinPoint is Monday.com. Training to cover these tools will be provided during or after SIV.

Patients should remain off meds between 1-2 months post procedure. If the patient meets escape criteria they should be put back on AHTN medication according to the medication escalation protocol in the study protocol.

Store immediately at -80 °C

Please double-check that the dedicated freezer is logged, locked, and alarmed; record any excursions on the temperature log.

We do not have a third-party vendor for patient compensation. There is a line item in the budget for it.

Yes. The protocol states that randomization will be generated by computer and stratified by center using blocks of small size and treatment permutation. The 2:1 (treatment to sham) stratification will be balanced at each site.

Yes, the patient would be eligible.

Uncontrolled and symptomatic.

Only if uncontrolled, please refer to medication protocol escalation.

We would defer to ethics committee.

Both can be treated if vessel diameter is >4mm. Review protocol angiographic criteria for complete information.

No.

Not required, but recommended (for on-med portion of the study).

We will provide noise cancelling headphones. Patients can use their own devices or, if not allowed, a hospital device (based on individual hospital requirements).

Medications to be modified at physician's discretion and with approval from sponsor.

We are not collecting treatment failure. An analysis may be done at the end of the trial to identify non-responders.

The steering committee says that while these drugs do influence blood pressure, they believe that GLP-1s are not exclusionary. We monitor medications throughout the study and can track their relationship with blood pressure. Also, because the study is randomized, GLP-1 use should appear in both study groups.