BOLT (Enrolling)

https://clinicaltrials.gov/ct2/show/NCT05003843

What is being investigated?

Penumbra's aspiration thrombectomy system in treating patients with deep vein thrombosis

Dr. Knowles

Sponsor: Penumbra Inc.

CRO: N/A

Contact: Valerie Abwavo Ngone vabwavongone@penumbrainc.com

EDC: Medrio https://identity.medrio.com/identity/login?signin=0c7092f04a4062bbffee3225a31b8ee6

Images: Ambra https://access.ambrahealth.com/

eTMF: NA

None in June and July. Please check Screening & Enrollment log and EPIC to stay on top of upcoming visits.

this is up to date as of 05 June 2023.

Back up coordinator: James Pierre-Louis
Screening: The enrolling investigators will let you know when they have a potential patient. I also keep an eye out for any lower extremity venograms on the cath lab schedule and screen them for eligibility.
Pre-procedure leg assessments/scores: I usually ask the vascular PA to assist me with those. It is considered a medical assessment that needs to be done by a medical provider. You can probably glean a lot of that information from chart review and asking the patient.
Patients get ClinCard payments for follow-ups.
Image upload: Upload procedural images.
Commercial rep is Marc Mayette ( 919-345-5439). You can expect to never have to contact him. Research coordinators have no obligation whatsoever to work with the commercial reps. Marc works very closely with the vascular surgeons and joins a lot of the procedures. I have found it helpful to check with him about device technicalities (esp. that one time where we had a device deficiency). But, again, communicate with him as much or as little as you wish.
Monitoring: They do on-site IMVs.
Data management: Penumbra has their own schedule of reviewing data so sometimes, there will be a flood of queries on the EDC, and they suddenly contact you LOT to follow up about those. They are very open to jump on a phone/Microsoft Teams call with you to review the queries if you would like.

Last updated 1 year ago