> For the complete documentation index, see [llms.txt](https://nchvr.gitbook.io/nchvr-guidebook/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://nchvr.gitbook.io/nchvr-guidebook/study-specific-information/necc-enrolling.md).
# 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@stryke](mailto:chris.gahm@strye)r.com
## Where to enter data and upload images?
**EDC:** iMedNet
**Images:** Judi AG Mednet [ ](https://judi.agmednet.net/)
**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](/nchvr-guidebook/downloading-imaging.md) 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)
