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 194 of 15
Severity: serious | Status: open | OVERDUE — immediate action required
COMPLAINT — SAE-002
Site 07 — Lyon
Day 183 of 15
Severity: complaint | Status: open | OVERDUE — immediate action required
Silent Site — 203 days no contact
Site 02 — Amsterdam
203 days silent
No communication for 203 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 194 days no contact
Site 04 — Hamburg
194 days silent
No communication for 194 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 188 days no contact
Site 05 — Vienna
188 days silent
No communication for 188 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 186 days no contact
Site 08 — Warsaw
186 days silent
No communication for 186 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 185 days no contact
Site 03 — Barcelona
185 days silent
No communication for 185 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 183 days no contact
Site 01 — Brussels
183 days silent
No communication for 183 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 182 days no contact
Site 07 — Lyon
182 days silent
No communication for 182 days (threshold: 14 days). Re-engagement recommended.
Silent Site — 181 days no contact
Site 06 — Milan
181 days silent
No communication for 181 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