NECC (Enrolling)

https://clinicaltrials.gov/ct2/show/NCT04852783

What is being investigated?

The Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms

Who is the PI?

Dr. Kass-Hout

Who is the sponsor and/or CRO? How to contact them?

Sponsor: Cerus Endovascular (Recently acquired by Stryker)

CRO: N/A

Contact: Chris Gahm chris.gahm@stryker.com

Where to enter data and upload images?

EDC: iMedNet https://www.imednet.com/

Images: Judi AG Mednet https://www.imednet.com/

eTMF: N/A

Upcoming Visits

001: 22 June 2023, 16:00, in Raleigh with Dr. Kass-Hout

005: 22 June 2023, 12:00, in Raleigh with Dr. Kass-Hout

Tips/Quirks

• Back up coordinator: Kyle, Allie

• This is the only study we have so far (and the first one!) with neuroendovascular. There are a few differences in workflow as compared to the cardiology & vascular surgery studies.

• Screening: The investigators, Dr. Kass-Hout and Dr. Becske (+ their NP Darcy Subramanian) are great about reaching out proactive about potential patients. You do not need to worry too much about screening. When they do send you a patient, just check again to make sure they fit criteria.

  • They are also great about explaining the study to patients! So, you may expect patients to have a general grasp of the study and device when you approach them.

• Consent usually happens at Pre-Admissions Testing (PAT) (~1-2 weeks before procedure day)

  • Darcy will coordinate this and usually informs you when it will be. If not, ask her, or check the patient's Epic appointment list

  • Location of PAT: Main Entrance of the Main Hospital

  • After consenting patient, you can upload the patient's baseline cerebral imaging to AG Mednet for sponsor approval

• Imaging approval by sponsors

  • This has to happen before the procedure begins

  • You will coordinate with Chris Gahm about this. He can push for expedited review if the turnaround time is tight.

  • If AG Mednet glitches (unfortunately, this is common), upload screenshots (.jpg, .png) of the aneurysm.

  • You will eventually need to upload full DICOM images, but we do not want that to hold up the approval process

• Chris Gahm and Stephen Griffin (former CEO of Cerus Endovascular; biomedical engineer who designed the device) will be on-site to support all enrollment cases. Please inform them of the procedure date as soon as it is confirmed so they can plan travel.

• Procedures were in the IR suite, but they are moving to the cath lab area in June 2023

• Patients get ClinCard payments for follow-ups.

• Follow-up visits: Contact Ashton Crawford who is the main RN at the clinic to schedule visits

  • Make sure to specify that the patients need to come in in-person (as far as possible) for neurological assessments. The neuro MDs do see a lot of patients via telehealth so it will be helpful to give Ashton a reminder that research patients need to come in.

  • Sometimes, follow-up visits are scheduled with short turnaround time. There has been times Ashton informed of a follow-up visit that just got scheduled 1-2 days in advance (or even on the day of!) That is not the norm but adaptability is key here.

• Clinic is located across the road (there is talk about them moving to the old Cancer Ceter in the main hospital, but not sure when)