STRIKE-PE (Enrolling)
https://clinicaltrials.gov/ct2/show/NCT04798261
What is being investigated?
Penumbra's aspiration thrombectomy system in treating patients with pulmonary embolism
Who is the PI?
Dr. Mendes (Note: Dr. Knowles has enrolled all the patients thus far)
Who is the sponsor and/or CRO? How to contact them?
Sponsor: Penumbra Inc.
CRO: N/A
Contact: Kenechi Madumelu kmadumelu@penumbrainc.com
Where to enter data and upload images?
Images: Ambra https://access.ambrahealth.com/
eTMF: Veeva Vault https://login.veevavault.com/ (This is where you upload redacted source documents)
EDC = Electronic Data Capture
eTMF = Electronic Trial Master File
Upcoming Visits
007 - Needs to be seen before 24 July 2023, or as early as possible. Please check if they have been scheduled. If not, follow up with Rex Vascular front desk staff.
011 - 365 day visit on 27 June 2023, 2pm. Wakefield. Seeing Kristie Clontz, PA-C.
012 - 365 day visit between 27 June - 25 Sep 2023. Scheduling in progress. Please check if they have been scheduled. If not, follow up with Rex Vascular front desk staff.
013 - 265 day visit on 17 July 2023, 12:30pm. Raleigh clinic. Seeing Dr. Knowles.
this is up to date as of 05 June 2023.
Tips/Quirks
Back up coordinator: James Pierre-Louis
Screening: The enrolling investigators will let you know when they have a potential patient. PE cases are usually acute and come through the ED. I do not really screen to look for patients. When investigators tell me about a patient, I check their chart to confirm eligibility.
The study technically allows for post-procedure consent. However, I would strongly recommend consenting the patient pre-procedure as a best practice. Dr Knowles is good about speaking with patients about this study, so they usually know most of the information by the time I approach them.
Image upload: Upload pre- and post- procedure CTAs and/or Echos (all that is available). No need to upload procedural imags.
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.
RV/LV ratios: We measure them from the CTA scans, there has been some back and forth about getting the ratio measurements from Echocardiograms. The answer is NO. We only do CTA measurements. If Penumbra gives you a hard time about this, redirect them to Dr. Mendes and explain that this has already been discussed.
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.
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