Surfacer System to Facilitate Access in Venous Occlusions

Study Overview
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Brief Summary
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Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.

Detailed Description
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This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated.

Official Title
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Surfacer System to Facilitate Access in Venous Occlusions

Conditions
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Chronic Venous Thrombosis, Venous Thrombosis Upper Extremity, Venous Thrombosis Upper Extremity Superficial Veins

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients referred for placement of a central venous catheter patients with limited or diminishing upper body venous access pathology impeding standard access methods signed informed consent Exclusion Criteria: vulnerable subjects or incapable of giving consent contraindications to central venous access based on treating physicians opinion or standard of care occlusion of the right femoral vein occlusion of the iliac vein occlusion of the inferior vena acute thrombosis within a vessel (IVC, brachiocephalic and subclavian)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of all acute safety and device related serious adverse event recorded on case report forms | overall complication rate compared to safety data | Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to place central venous access catheter using Surfacer system | performance evaluated by procedure time measured by time to create access | Procedure | 
| Surfacer system advancement of the exit wire outside the vein | Ability to advance system from femoral vein to supraclavicular exit as measured by time | procedure | 
| Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents | introducing a standard central venous access catheter over the needle wire | procedure |