WAVE (Enrolling)

https://clinicaltrials.gov/ct2/show/NCT04540302

What is being investigated?

The WRAPSODY covered stent for treating stenoses in AV dialysis access circuits.

Who is the PI?

Dr. Mendes

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

Sponsor: Merit Medical

CRO: N/A

Contact: Jim Hobbs jim.hobbs@merit.com

Where to enter data and upload images?

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

Images: AG Mednet https://judi.agmednet.net/#!/login

eTMF: Florence https://login.v2.researchbinders.com/u/login/identifier?state=hKFo2SBONEZ2RHg3Sll5c3EyUndSYVE1LWFjQ19Qb3VsR2NnZKFur3VuaXZlcnNhbC1sb2dpbqN0aWTZIG8wWVF4U3U0TGVKcjJIM0xOUEtYYU9aWGg0NF9xRkcxo2NpZNkgQkJkbHpjR1oxWGZDNmxQeXdVSTFDUUJpWnpFbmJYRk8 (you rarely need to access this)

Screening Log: Smartsheet https://app.smartsheet.com/b/home?dlp=%2Fsheets%2FVM93W688jg95prHGg45GhRV2R49c77Rgf2MhFfP1&dlq=view%3Dgrid

Upcoming Visits

001 (the only patient enrolled) is due for follow-up between 12 July - 9 Dec 2023. Please check EPIC to see if they have been scheduled, if not, please follow up with Rex Vascular front desk.

Note: This patient tends to have a lot of AEs due to back pain and other dialysis issues. On multiple occasions, he has missed or left early from dialysis and had to come in to the hospital for urgent dialysis. Just keep an eye out on this and make sure AEs are reported.

this is up to date as of 05 June 2023.

Tips/Quirks

  • Back up coordinator: Jenn VanDuine.

  • Screening: Look for patients scheduled for shuntograms/fistulagrams.

  • Keeping the Smartsheets screening log up to date: I normally update it every 1-2 weeks instead of every time I screen. Feel free to find a system of keeping track of the super large number of screened patients that works for you.

  • This study is VERY hard to enroll in due to their criteria. MOST patients do not meet general I/E criteria, those that do tend to end up being angiographic screen fails. Persevere with screening, but manage expectations.

  • The field specialist, Jim Hobbs, is super helpful. He tries to be on-site to support enrollment cases as far as possible. When you do find a potential patient, email him with the time/date of procedure. If you have any doubts about patient eligibility, he is your point person to check. I have send him redacted patient notes (bc PHI is redacted, it is OK to send) to double check.

  • Patients get ClinCard payments for follow-ups.

  • Some devices expire this fall, so you can expect the sponsor to contact you about shipping them back. If you do enroll a patient, try your best to use the near-expiration devices.

  • Monitoring: They do on-site IMVs. The monitors have high turnover. We have had 3 IMVs so far, each time with a different person. Monitors tend to make their initial contact via phone instead of email, which I do not love. I always ask them to send an email and make a IMV request in writing.

PreviousBOLT (Enrolling)NextNECC (Enrolling)

Last updated