This is a prospective, single-center, first-in-man, proof-of-concept study to be conducted at Auckland City Hospital, Auckland, New Zealand to evaluate the safety and performance of the Tetherx NVS System in subjects with femoropopliteal atherosclerosis, Rutherford category 2-4.

Tetherx, Inc.0 个研究点目标入组 30 人开始时间: 2011年8月23日最近更新: 2020年1月13日

研究概览

暂无简介。

•I1Age > 18 years and < 85 years
•I2Subject or subject’s legal representative have been informed of the nature of the study, agrees to participate and has signed an EC approved consent form
•I3Female subjects of childbearing potential have a negative pregnancy test at 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
•I4Subject understands the duration of the study and its follow up visit requirements
•I5Subject has documented claudication or ischemic rest pain in the target limb prior to the study procedure with documented Rutherford category 2, 3, or 4
•I6Subject is able to walk unassisted
•I7Subject has a documented resting ABI < 0.9 or a toe brachial index (TBI) performed (if ABI non-diagnostic) prior to enrollment

•I1Life expectancy < 12 months (in the Investigator’s opinion)
•I2Debilitating cerebrovascular accident (CVA) or ST Segment Myocardial Infarction (STEMI) within the 3 months prior to enrollment
•I3Administration of local systemic thrombolytics for acute limb ischemia (ALI) within the previous 30 days
•I4Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or the NVS vascular polyethylene glycol (PEG) solution
•I5Allergy to contrast media that cannot be adequately pre-treated prior to procedure
•I6Chronic renal insufficiency with serum creatinine > 2.5 mg/dL
•I7Untreatable bleeding diatheses, hypercoagulable state, thrombocytopenia, and/or other bleeding disorder unresponsive to or not improved by blood transfusion
•I8Systemic infection present or suspected
•I9Enrolled in another investigational device, drug, or biologic study in which the subject has not completed the follow-up requirements
•I10There is an additional planned percutaneous intervention (cardiac/peripheral) < 30 days following the study procedure
•I11Subject is breast-feeding or plans to become pregnant during the follow-up period
•I12Previous lower limb amputation, excluding toe amputations

发起方

Tetherx, Inc.