Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

Inclusion Criteria:

• Patients aged between 18 and 75 years (inclusive)
• CVI patients with painful swelling and/or skin changes and/or recurrent leg ulcerdespite optimal conservative treatment for a period of time according to theinvestigator's judgement
• Patients with deep venous reflux (grade 3 and above)
• Meeting ASA (American Society of Anesthesiologists Classification) class 1 or 2according to the PIs criteria
• Laboratory values
• INR <1.7 (in case the patient uses Warfarin, the test might be repeated after theanticoagulant change)
• Platelets ≥ 100 x 10 9 /L
• Hemoglobin ≥ 100 g/L
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• ASAT ≤ 2.5 × ULN
• ALAT ≤ 2.5 × ULN
• Ability to understand the requirements of the study, give direct or representativewritten informed consent, and comply with the study procedures

Exclusion Criteria:

• Patients incapable to give direct or representative written informed consent
• Patients unlikely to cooperate fully in the study and/or with an anticipated poorcompliance
• Non-walking patients or patients with lost ankle joint function
• Patients previously organ-transplanted
• Patients with cancer except in-situ stage cancer (basal-cell carcinomas and/or cervixcancer) and five year recurrence free period after treatment
• Patients with autoimmune diseases including rheumatoid arthritis, SLE and MS
• Pregnant or breast feeding women
• Patients with ongoing estrogen treatment for example for contraception. Alternativecontraceptive methods (e.g. intrauterine device, bilateral tubal occlusion,vasectomized partner, sexual abstinence) should be used by women of reproductive age (defined as pre-menopausal female capable of becoming pregnant).
• BMI ≥ 35
• Patients who have participated in other clinical trials during the last 12 months
• Patients with artery pathology (ankle-brachial pressure index < 0,9 or > 1,3)
• Patients with thrombophilia according to the laboratory results at inclusion visit.One of the following criteria is needed for thrombophilia: Protein C < 40% or ProteinS < 40 % or Leiden factor mutation or Antithrombin III < 40 % or present Lupusanticoagulant or Homocysteine > 1.5 ULN
• Patients with an active infection requiring systemic antibiotic treatment
• Patients with clinically significant cardiac disease (New York Heart Association,Class III or IV) or measured LVEF 40%
• Patients with uncontrolled hypertension
• Patients with renal dysfunction eGFR < 45 ml/min (according to the MDRD calculation)
• Patients with moderate or severe hepatic impairment (Child Pugh ≥ 7 points, i.e. classB or C)
• Patients with ongoing immunosuppression, systemic Cortisol treatment etc.
• Less than 3 months since previous ipsilateral venous intervention (e.g. Iliacrecanalization)
• Clinically significant iliocaval stenosis or occlusion
• Current smoker of more than 20 cigarettes per day
• Other uncontrolled intercurrent illness that would jeopardize the patient's safety,interfere with the objectives of the protocol, or limit the patient's compliance withstudy requirements, as determined by the Investigator in consultation with the Sponsor
• Patients with severe SARSCoV-2 virus infection requiring hospitalization in the past 6months