Tissue Engineered Veins in Patients With Chronic Venous Insufficiency

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 poor compliance
• •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 cervix cancer) 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. Alternative contraceptive 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 Protein S \< 40 % or Leiden factor mutation or Antithrombin III \< 40 % or present Lupus anticoagulant 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. class B or C)
• •Patients with ongoing immunosuppression, systemic Cortisol treatment etc.
• •Less than 3 months since previous ipsilateral venous intervention (e.g. Iliac recanalization)
• •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 with study requirements, as determined by the Investigator in consultation with the Sponsor
• •Patients with severe SARSCoV-2 virus infection requiring hospitalization in the past 6 months