Question 1

Will SoniVie/Boston Scientific be using a central laboratory?

Accepted Answer

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.

Question 2

Will SoniVie/Boston Scientific be needing access to site's EMR in order for the screeners to contact potential patients?

Accepted Answer

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.

Question 3

How are the patients screened?

Accepted Answer

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.

Question 4

What PHI protections are in place for this process?

Accepted Answer

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.

Question 5

What are all the timepoints and escape criteria that patients can crossover?

Accepted Answer

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.

Question 6

Does one person at the site need to be blinded and the other unblinded?

Accepted Answer

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.

Question 7

What website will be used for the campaign?

Accepted Answer

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.

Question 8

Is the titration between 1-2 months based on the Home BP?

Accepted Answer

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.

Question 9

At what temperature do the urine concentration samples need to be stored?

Accepted Answer

Store immediately at -80 °C
Please double-check that the dedicated freezer is logged, locked, and alarmed; record any excursions on the temperature log.

Question 10

Will subject compensation be paid by site or a third-party vendor (e.g.: Greenphire)?

Accepted Answer

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

Question 11

Will the 2:1 (treatment to sham) stratification will be balanced at each site?

Accepted Answer

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.

Question 12

In case of hypothyroidism, if corrected, would the patient be eligible?

Accepted Answer

Yes, the patient would be eligible.

Question 13

What is the definition of rapid AFIB criteria?

Accepted Answer

Uncontrolled and symptomatic.

Question 14

Are we required to put patients back on medication after two months?

Accepted Answer

Only if uncontrolled, please refer to medication protocol escalation.

Question 15

If patient becomes pregnant during the study do we withdraw them?

Accepted Answer

We would defer to ethics committee.

Question 16

Are we going to be treating only main artery? Or artery and accessories?

Accepted Answer

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

Question 17

If previously treated for PAD, can catheter go through a stent?

Accepted Answer

No.

Question 18

Do the patient study visits need to be done before 10am?

Accepted Answer

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

Question 19

What about the BlueTooth, would they bring in their phone? What about people that do not have BlueTooth phone/music?

Accepted Answer

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

Question 20

What if patient has a known intolerance to an ARB?

Accepted Answer

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

Question 21

Is there treatment failure?

Accepted Answer

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

Question 22

How to manage subjects who are taking GLP-1s?

Accepted Answer

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.

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