Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is being measured
- What the trial is trying to show
Trial overview
The available study investigates ALLOGENEIC VEIN TISSUE SEGMENT, DECELLULARISED, WITH A FUNCTIONAL VALVE PERFUSED WITH AUTOLOGOUS PERIPHERAL BLOOD in patients with chronic venous insufficiency.[1] The trial is authorised, interventional, and plans to enroll 60 people.[1]
The title describes the study as a Phase II/III randomized controlled open-label trial, while the phase field lists Phase 4.[1] This means the source uses more than one phase label, so both are shown here exactly as reported.[1]
Who can participate
The target population is patients with severe chronic venous insufficiency.[1] The brief summary says the study is aimed at people with severe CVI, so the trial is focused on advanced disease rather than mild symptoms.[1]
The source data do not provide more detailed inclusion or exclusion rules, such as age limits or other health conditions.[1]
Study design and phase
This is an interventional study, which means participants receive a treatment and the results are measured over time.[1] It is also described as randomized controlled and open-label.[1]
Randomized controlled means people are assigned to groups by chance, so the treatment can be compared with a control group fairly.[1] Open-label means the participants and the study team know which treatment is being given.[1]
The intervention listed in the source is Personalized Tissue Engineered Vein, given as implantation.[1]
What is being measured
The main outcome is valve competency at 6 months after implantation, compared with control, using Color Duplex Ultrasound to measure reflux.[1] Valve competency means how well the valve closes and stops blood from flowing backward.[1]
The second main outcome is the change in rVCSS score at 6 months after implantation, compared with control.[1] The rVCSS is a score used to track signs and symptoms of venous disease, so a lower score suggests improvement.[1]
The brief summary explains that the study wants to show two things: disease-modifying efficacy and clinical efficacy.[1] Disease-modifying efficacy means the trial is checking whether the treatment can improve the underlying vein problem, not only symptoms.[1]
What the trial is trying to show
The trial aims to demonstrate that the personalized tissue engineered vein with valves may reduce deep venous valve pathology in patients with severe CVI.[1] In simple terms, the study is looking at whether the treatment can help damaged vein valves work better.[1]
It also aims to show improvement in the clinical signs and symptoms of chronic venous insufficiency.[1] The key time point for both main outcomes is 6 months after implantation.[1]
