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Study: Post-Market Clinical Follow-Up Study of the VascuPath 3F Interventional Catheter

Protocol: PMCF-2024-CAT-001 | Status: Active | Device: VascuPath 3F Interventional Catheter (Class IIb)

Overall enrollment: 94 / 120 (78%)


Overdue Escalations

2 overdue item(s) requiring escalation
SAE SAE-001 at Site 04 — Hamburg — Day 74 of 15 — 0 day(s) overdue
COMPLAINT SAE-002 at Site 07 — Lyon — Day 63 of 15 — 0 day(s) overdue

Total Sites

8

8 active

Open SAEs

2

2 overdue

Open Communications

3

3 pending review

Silent Sites

8

Exceeding contact threshold


CRA Performance

CRA Sites Assigned Open Items Overdue Items Last Activity
Sarah Mitchell 8 3 2 14 Mar 2026 08:30

Site Portfolio

Site # City Country PI Enrolled Last Contact Flags Actions
01 Brussels BE Dr. Elise Van den Berg 14/15 12 Mar 2026 SILENT View
02 Amsterdam NL Dr. Pieter Hoekstra 11/15 20 Feb 2026 SILENT View
03 Barcelona ES Dr. Carmen Fernández 13/15 10 Mar 2026 SILENT View
04 Hamburg DE Dr. Friedrich Richter 12/15 01 Mar 2026 OVERDUE SAE SILENT View
05 Vienna AT Dr. Stefan Gruber 10/15 07 Mar 2026 SILENT View
06 Milan IT Dr. Marco Conti 12/15 14 Mar 2026 SILENT View
07 Lyon FR Dr. Isabelle Lefebvre 11/15 13 Mar 2026 OVERDUE SAE SILENT View
08 Warsaw PL Dr. Tomasz Kowalski 11/15 09 Mar 2026 SILENT View

Enrollment Progress by Site

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