Clinical trial NCT02875899: Surfacer System to Facilitate Access in Venous Occlusions
Official title: Surfacer System to Facilitate Access in Venous Occlusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Thrombosis
Venous Thrombosis Upper Extremity
Venous Thrombosis Upper Extremity Superficial Veins
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients requiring central venous access for:

* dialysis
* chemotherapy nutrition
* delivery of any pharmacological therapy

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Absence of all acute safety and device related serious adverse event recorded on case report forms
timeFrame: Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.
Secondary outcomes:
measure: Ability to place central venous access catheter using Surfacer system
timeFrame: Procedure
measure: Surfacer system advancement of the exit wire outside the vein
timeFrame: procedure
measure: Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents
timeFrame: procedure
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
state: Waehringer Guertel 18-20
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Dusseldorf
country: Germany
facility: Schon Klinik
city: Milan
country: Italy
facility: Azienda Ospedaliera San Carlo Borromeo
Study officials:
affiliation: Bluegrass Vascular
name: Laura Minarsch, RT
role: STUDY_DIRECTOR
References:
citation: Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC. Inside-out access: a new method of lead placement for patients with central venous occlusions. Heart Rhythm. 2011 Jun;8(6):851-7. doi: 10.1016/j.hrthm.2011.01.024. Epub 2011 Jan 13.
citation: Frykholm P, Pikwer A, Hammarskjold F, Larsson AT, Lindgren S, Lindwall R, Taxbro K, Oberg F, Acosta S, Akeson J. Clinical guidelines on central venous catheterisation. Swedish Society of Anaesthesiology and Intensive Care Medicine. Acta Anaesthesiol Scand. 2014 May;58(5):508-24. doi: 10.1111/aas.12295. Epub 2014 Mar 5.
citation: Baskin JL, Pui CH, Reiss U, Wilimas JA, Metzger ML, Ribeiro RC, Howard SC. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009 Jul 11;374(9684):159-69. doi: 10.1016/S0140-6736(09)60220-8.