Clinical Studies
Post-Market Clinical Follow-Up Study of the VascuPath 3F Interventional Catheter
PMCF-2024-CAT-001 · VascuPath 3F Interventional Catheter · PMCF
Open Items
3
Communications requiring action
Pending Reviews
3
Awaiting human review
Open SAEs
2
Active safety events
Overdue
2
Past regulatory deadline
Priority Queue — Action Required
SAE — SAE-001
Site 04 — Hamburg
Day 254 of 15
Severity: serious | Status: open | OVERDUE — immediate action required
COMPLAINT — SAE-002
Site 07 — Lyon
Day 243 of 15
Severity: complaint | Status: open | OVERDUE — immediate action required
Silent Site — 262 days no contact
Site 02 — Amsterdam
262 days silent
No communication for 262 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 253 days no contact
Site 04 — Hamburg
253 days silent
No communication for 253 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 247 days no contact
Site 05 — Vienna
247 days silent
No communication for 247 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 245 days no contact
Site 08 — Warsaw
245 days silent
No communication for 245 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 244 days no contact
Site 03 — Barcelona
244 days silent
No communication for 244 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 242 days no contact
Site 01 — Brussels
242 days silent
No communication for 242 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 241 days no contact
Site 07 — Lyon
241 days silent
No communication for 241 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 240 days no contact
Site 06 — Milan
240 days silent
No communication for 240 days (threshold: 14 days). Re-engagement recommended.
Protocol Deviation Notification — Visit Window Exceeded — Subject 06-0
Site 06 — Milan
Received: 14 Mar 2026 08:30
Category: Protocol Deviation | Classification: classified | Confidence: 90%
Site Status Overview
01 — Brussels
PI: Dr. Elise Van den Berg
02 — Amsterdam
PI: Dr. Pieter Hoekstra
03 — Barcelona
PI: Dr. Carmen Fernández
04 — Hamburg
PI: Dr. Friedrich Richter
05 — Vienna
PI: Dr. Stefan Gruber
06 — Milan
PI: Dr. Marco Conti
07 — Lyon
PI: Dr. Isabelle Lefebvre
08 — Warsaw
PI: Dr. Tomasz Kowalski