drugset / Trial / NCT03784131

Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

NCT03784131 ↗

Phase 1 Unknown 15 enrolled Verigraft AB
NaSingle-groupOpen-labelTreatment

Summary

This study aims to evaluate the safety (incidence of adverse events including serious adverse events and clinical significant laboratory abnormalities) of personalized tissue engineered veins (P-TEV) with valves implanted in patients with severe chronic venous insufficiency (CVI). For each patient a segment of the femoral vein containing the non-functioning valve will be surgically replaced with a single P-TEV containing a functioning valve.

Timeline

Start
2021-12-15
Primary completion
2025-06
Completion
2025-06

Drugs

EvaluationDrugModalityDoseRoute
Subject P-TEV Other / unclassified — Other