In treating patients with Critical Limb Ischaemia (CLI) using Hypertensive Extracorporeal Limb Perfusion(HELP) when compared to conventional treatments the study evaluates Safety and Efficacy via a multicentre, controlled trial.

Advanced Surgical Design and Manufacture0 个研究点目标入组 40 人开始时间: 2010年2月4日最近更新: 2020年1月13日

试验速览

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•1) Only alternative treatment is imminent (within 8 weeks) major limb amputation
•2) At least two vascular surgeons must agree that the treatment is the only remaining option for the patients
•3) Patients must be over 18 years of age
•4) Patients have critical limb ischaemia
•5) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
•6) Patients must be fit for anaesthesia
•7) Patients must have suitable anatomy determined by pre-operative imaging and physical examination

•1) Patients must not be in a concurrent clinical trial
•2) Patient must not have compartment syndrome
•3) Patients must not have an active systemic infection
•4) Patient must not have serum abnormalities or high Creatine Phosphokinase (CPK) (greater than 3x the upper limit of normal for the testing laboratory) as deemed by the clinical investigator
•5) Patients must not have general advanced debilitation or intercurrent organ failure
•6) Patients must not have a serious wound infection (for example, Methicillin-resistant Staphylococcus aureus (MRSA) of the ulcer) that in the opinion of the Clinical Investigator may impede the response to treatment
•7) Patients must not have disseminated intravascular coagulation (DIC) as deemed by the clinical investigator

发起方

Advanced Surgical Design and Manufacture