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Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

NCT03784131 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Chronic Venous Insufficiency

Interventions

DRUG

P-TEV

Replacement of vein with failing valves with personalized tissue engineering vein containing functional valves

Sponsors & Collaborators

  • Verigraft AB

    lead INDUSTRY

Principal Investigators

  • Björquist · Verigraft AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784131 on ClinicalTrials.gov