Table of Contents
- Trial overview
- Who is being studied
- Study design and phase
- What the trial measures
- What the study seeks to show
Trial overview
The clinical trial in the source data is an interventional study of 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 and includes 60 participants.[1]
The study title describes it as a Phase II/III randomized controlled open-label trial, while the phase field lists Phase 4.[1] This means the research is comparing treatment groups in a planned way and is focused on how well the treatment works and how safe it is in real patients.[1]
Who is being studied
The target population is people with chronic venous insufficiency, especially those with severe CVI.[1] The brief summary says the study is intended to show benefit in patients with severe disease, including effects on deep venous valve problems and on symptoms.[1]
Chronic venous insufficiency is a long-term vein problem in which blood does not return to the heart properly.[1] In this trial, the focus is on patients whose vein valves are not working well enough and who may have ongoing clinical signs and symptoms.[1]
Study design and phase
This is an interventional study, which means participants receive the study treatment and the results are measured afterward.[1] It is also described as randomized controlled, meaning participants are assigned to groups by chance so the treatment can be compared with control care.[1]
The study is open-label, so the treatment assignment is not hidden from participants or researchers.[1] The intervention listed is a drug named Personalized Tissue Engineered Vein, given as implantation.[1]
What the trial measures
The main outcome is valve competency at 6 months after implantation compared with control, measured using Color Duplex Ultrasound to check for reflux.[1] Valve competency means how well the valve closes and prevents blood from flowing backward.[1]
The second main outcome is rVCSS score reduction at 6 months after implantation compared with control.[1] The rVCSS is a score used to track clinical signs and symptoms of chronic venous insufficiency, so a drop in the score suggests improvement.[1]
The study summary also says the researchers want to show disease-modifying efficacy and clinical efficacy.[1] In simple terms, this means they want to see whether the treatment can change the course of the vein disease itself and also improve how patients feel and function.[1]
What the study seeks to show
The first goal is to reduce deep venous valve pathology in patients with severe chronic venous insufficiency.[1] Deep venous valve pathology means damage or disease in the valves inside deep veins, which can lead to backward blood flow.[1]
The second goal is to reduce the clinical signs and symptoms of chronic venous insufficiency.[1] This makes the trial important for understanding whether the treatment can help both the vein function and the patient’s day-to-day disease burden.[1]
