2025-524103-69-00招募中3 期
Phase II/III randomized controlled open-label trial to evaluate the efficacy and safety of personalized tissue engineered veins in patients with chronic venous insufficiency
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- VeriGraft AB
- 入组人数
- 60
- 试验地点
- 14
研究概览
简要总结
To demonstrate the efficacy of P-TEV grafts with valves in the reduction of deep venous valve pathology in patients with severe CVI (Disease-modifying efficacy).
To demonstrate the efficacy of P-TEV grafts with valves in the reduction of clinical signs and symptoms of CVI in patients with severe CVI (Clinical efficacy).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or Female patients aged between 18 and 75 years old
- •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
- •Patients with significant femoral deep venous reflux
- •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
排除标准
- •Patients incapable of giving direct or representative written informed consent
- •Patients who plan to participate in other clinical trials or have participated in other clinical trials during the past 3 months
- •Patients with arterial pathology (ankle-brachial pressure index < 0,9 or > 1,3)
- •Patients with thrombophilia that cannot be controlled with antithrombotic drugs
- •Patients with an active infection requiring systemic antibiotic treatment
- •Patients with clinically significant cardiac disease (NYHA Class III or IV), measured LVEF ≤ 40% or an acute cardiac event in the past 6 months
- •Patients with uncontrolled hypertension
- •Patients with renal dysfunction eGFR < 45 ml/min
- •Patients with severe hepatic impairment
- •Patients with ongoing immunosuppression, systemic Cortisol treatment etc
- •Less than 3 months since previous ipsilateral venous intervention (e.g. recanalization)
- •Patients unlikely to cooperate fully in the trial and/or with anticipated poor compliance
- •Clinically significant iliocaval stenosis or occlusion
- •Patients with severe SARSCoV-2 virus infection requiring hospitalization during the past 6 months
- •Patients meeting ASA (American Society of Anesthesiologists Classification) ≥ 4
- •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
- •Non-walking patients or patients with impaired ankle joint function
- •Patients previously organ-transplanted
- •Patients with cancer except in-situ cancer or a five-year recurrence free period after treatment
- •Patients with autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus and multiple sclerosis
- •Pregnant or breast-feeding women
- •Patients with ongoing estrogen treatment
- •Patients with a BMI ≥ 38 or a degree of obesity leading to expected difficulty in surgery or motion according to Investigator’s opinion
研究组 & 干预措施
Personalized Tissue Engineered Vein
Test
干预措施: Personalized Tissue Engineered Vein (Drug)
研究者
Raimund Strehl
Scientific
VeriGraft AB
研究点 (14)
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