ISRCTN79284836
Completed
未知
Prospective multi-centre observational pilot study to investigate the safety and efficacy of the Venous Window Needle GuideTM (VWNG) (SAVE-2 study)
Central Manchester University Hospitals NHS Trust (CMFT) (UK)0 sites60 target enrollmentJuly 29, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Central Manchester University Hospitals NHS Trust (CMFT) (UK)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The participant has an un\-cannulatable (per the provided definition) upper arm or forearm cephalic, basilic or brachial vein outflow arteriovenous (AV) fistula AND/OR the subjects and their clinicians opt for self\-cannulation
- •2\. The participant has received or is in imminent need of receiving haemodialysis treatment and will receive in\-center or home haemodialysis treatments at least two times per week
- •3\. Subject?s fistula diameter is at least 5 mm at the planned site of device attachment
- •4\. Buttonhole cannulation technique is appropriate for the subject
- •5\. Subject?s fistula does not have clinically significant flow abnormalities and has adequate fistula flow (\=400 ml/min) to achieve optimum dialysis or dialysis as prescribed
- •6\. The AV fistula is in the range of 4 to 15 mm in depth at the anticipated VWNG access site(s)
- •7\. Subject?s life expectancy is at least 1 year, based on clinician?s assessment of medical condition
- •8\. The participant has understood the Informed Consent and has agreed to participate in the study
- •9\. Target Gender: Male \& Female ; Lower Age Limit 18 years
Exclusion Criteria
- •1\. Subject has recent (within past month) occurrence and/or intervention for AV access stenosis or thrombosis
- •2\. Subject has AV fistula that has undergone a major revision such as AVF resection with PTFE graft insertion, vascular stent placement at cannulation site, complete ligation or closure, requires construction of new anastomosis, a flow\-limiting procedure including a DRIL or banding procedure or surgical intervention for an aneurysm at the implant site
- •3\. Subject has skin infection, hypersensitive skin or skin allergies at potential implant sites
- •4\. Subject is pregnant
- •5\. Subject has Body Mass Index \> 50
- •6\. Subject has known bleeding disorder based on medical history and clinical observations, e.g., low platelet count
- •(\<50,000\), hypercoagulable state, e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating Lupus anticoagulant; active heparin\-induced thrombocytopenia; Protein C or S deficiency; or history of recurrent deep vein thrombosis not related to AV access.
- •7\. Subject has active malignancy, e.g., condition either being treated or considered untreatable
- •8\. Subject has active systemic infection, e.g., condition either being treated or considered untreatable or positive blood culture
- •9\. Subject has history of significant cardiovascular event/intervention such as angioplasty or stent placement within the previous 3 months, or myocardial infarction within the previous 6 months.
Outcomes
Primary Outcomes
Not specified
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