ALLOGENEIC VEIN TISSUE SEGMENT, DECELLULARISED, WITH A FUNCTIONAL VALVE PERFUSED WITH AUTOLOGOUS PERIPHERAL BLOOD for Chronic venous insufficiency

Inclusion criteria

• {"criterion_text":"- Male or Female patients aged between 18 and 75 years old"}
• {"criterion_text":"- CVI patients with painful swelling and/or skin changes and/or recurrent leg ulcer despite optimal conservative treatment for a period according to the Investigator’s judgement"}
• {"criterion_text":"- Patients with significant femoral deep venous reflux"}
• {"criterion_text":"- Lab values: INR <1.7 (patient on Warfarin, may repeat the test after anticoagulant change); Platelets ≥ 100 x 109/L; Hemoglobin ≥ 100 g/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN) o ASAT ≤ 2.5 × ULN; ALAT ≤ 2.5 × ULN; Lipid profile within acceptable range according to Investigator’s opinion; Clinical chemistry within acceptable range according to Investigator’s opinion"}

Exclusion criteria

• {"criterion_text":"- Patients incapable of giving direct or representative written informed consent"}
• {"criterion_text":"- Patients who plan to participate in other clinical trials or have participated in other clinical trials during the past 3 months"}
• {"criterion_text":"- Patients with arterial pathology (ankle-brachial pressure index < 0,9 or > 1,3)"}
• {"criterion_text":"- Patients with thrombophilia that cannot be controlled with antithrombotic drugs"}
• {"criterion_text":"- Patients with an active infection requiring systemic antibiotic treatment"}
• {"criterion_text":"- Patients with clinically significant cardiac disease (NYHA Class III or IV), measured LVEF ≤ 40% or an acute cardiac event in the past 6 months"}
• {"criterion_text":"- Patients with uncontrolled hypertension"}
• {"criterion_text":"- Patients with renal dysfunction eGFR < 45 ml/min"}
• {"criterion_text":"- Patients with severe hepatic impairment"}
• {"criterion_text":"- Patients with ongoing immunosuppression, systemic Cortisol treatment etc"}
• {"criterion_text":"- Less than 3 months since previous ipsilateral venous intervention (e.g. recanalization)"}
• {"criterion_text":"- Patients unlikely to cooperate fully in the trial and/or with anticipated poor compliance"}
• {"criterion_text":"- Clinically significant iliocaval stenosis or occlusion"}
• {"criterion_text":"- Patients with severe SARSCoV-2 virus infection requiring hospitalization during the past 6 months"}
• {"criterion_text":"- Patients meeting ASA (American Society of Anesthesiologists Classification) ≥ 4"}
• {"criterion_text":"- Patients with other uncontrolled intercurrent illness that would jeopardize the patient’s safety, interfere with the objectives of the protocol, or limit the patient’s compliance with study requirements, as determined by the Investigator together with the Sponsor"}
• {"criterion_text":"- Non-walking patients or patients with impaired ankle joint function"}
• {"criterion_text":"- Patients previously organ-transplanted"}
• {"criterion_text":"- Patients with cancer except in-situ cancer or a five-year recurrence free period after treatment"}
• {"criterion_text":"- Patients with autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus and multiple sclerosis"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Patients with ongoing estrogen treatment"}
• {"criterion_text":"- Patients with a BMI ≥ 38 or a degree of obesity leading to expected difficulty in surgery or motion according to Investigator’s opinion"}

Primary endpoints

• {"endpoint_text":"- Valve competency at 6 months post P-TEV implantation vs control (using Color Duplex Ultrasound to measure reflux)","definition_or_measurement_approach":"Measured using Color Duplex Ultrasound to assess reflux and valve competency at 6 months post-implantation compared with control"}
• {"endpoint_text":"- rVCSS score reduction at 6 months post implantation vs control (using the rVCCS)","definition_or_measurement_approach":"Measured as reduction in rVCSS score at 6 months post-implantation versus control using the rVCSS/rVCCS scoring instrument"}

Secondary endpoints

• {"endpoint_text":"- Valve competency at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound)","definition_or_measurement_approach":"Measured using Color Duplex Ultrasound at 1, 3, 6 and 12 months compared with pre-implantation"}
• {"endpoint_text":"- Change in hemodynamics / reflux time at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound)","definition_or_measurement_approach":"Change in hemodynamics/reflux time measured by Color Duplex Ultrasound at specified timepoints versus pre-implantation"}
• {"endpoint_text":"- Relief of clinical signs and symptoms at 1, 3, 6, 12 months post-implantation vs pre-implantation (Ankle + calf circumference, VEINES-SYM, rVCSS, CEAP/Villalta score))","definition_or_measurement_approach":"Clinical signs and symptoms assessed via ankle and calf circumference measurements and validated scores (VEINES-SYM, rVCSS, CEAP/Villalta) at specified timepoints versus baseline"}
• {"endpoint_text":"- Ulcer healing at 1, 3, 6, 12 months post-implantation vs pre-implantation (ulcer number, location, area and depth)","definition_or_measurement_approach":"Ulcer healing assessed by number, location, area and depth measurements at specified timepoints versus baseline"}
• {"endpoint_text":"- Vein disease related QoL (VEINES-QOL) and general health-related QoL (SF-36/6D) at 1, 3, 6, 12 months post-implantation vs pre-implantation","definition_or_measurement_approach":"Quality of life measured using VEINES-QOL and SF-36/6D instruments at specified timepoints versus baseline"}
• {"endpoint_text":"- Product related and surgical procedure related adverse events (Safety)","definition_or_measurement_approach":"Safety assessed as incidence and nature of product-related and procedure-related adverse events"}

Spain

Earliest CTIS Part Ii Submission Date

19-03-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

39

Number Of Sites

14

Number Of Participants

60

Primary sponsor

Full Name

VeriGraft AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden