Transcend (Follow-up)

https://clinicaltrials.gov/ct2/show/NCT03241459

What is being investigated?

SurVeil drug-coated balloon for treating peripheral artery disease in the femoral and popliteal arteries.

Who is the PI?

Dr. Sachar

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

Sponsor: Surmodics

CRO: Namsa

Contact: Ashley Renning arenning@namsa.com

Where to enter data and upload images?

EDC: Zelta (formerly IBM) https://zeltatrials.com/ng/login

Images: NA

eTMF: NA

Upcoming Visits

019: Visit window already ended on 11 Jun 2023. I have been unable to reach her. She had cancelled several previous in-office appointments, and then was recently hospitalized. Please call the patient as soon as possible and document that as an Out-Of-Window visit.

040: Visit window ends on 30 Aug 2023. Please call the patient for follow-up.

050: Visit window already ended on 02 May 2023. Both I and the clinic schedulers have tried to reach out to her multiple times to follow up. It has been a while since the window ended. I would say you can try to call her a few more times as an Out-Of-Window visit, or mark it as a missed visit and schedule/call during the next visit window.

this is up to date as of 14 June 2023.

Tips/Quirks

  • Back up coordinator: Soumya Sidana

  • Patients are all at the 48 or 60-month visit mark by now, which means as far as the study is concerned, follow-up visits can be done by phone. The caveat:

    • Patients get a ClinCard payment for in-person visits, but not phone visits

  • I usually read their last study-related visit note and see if I can "coincide" a research visit with when their provider wants them to come back. If not, I just call them.

  • Certain patients tend to have many AEs, keep an eye out and stay on top of reporting.

  • Monitoring: On-site IMVs. They come about once a year. It is usually a different monitor each year.

    • They ask for all of the patient's concomitant medications during study participation to be reported. This is the most complicated part because patients are started and stopped on different medications all the time, for various reasons. This will likely be the biggest pain point during IMVs.

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