Surfacer System to Facilitate Access in Venous Occlusions

Chronic Venous Thrombosis Clinical Trial

— SAVE  

Official title:

Surfacer System to Facilitate Access in Venous Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875899
• Other study ID #: CP0002
• Status: Completed
• Start date: February 7, 2017
• Est. completion date: October 4, 2018

Study information

• Verified date: January 2024
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 4, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Venous Thrombosis
• Thrombosis
• Venous Thrombosis
• Venous Thrombosis Upper Extremity
• Venous Thrombosis Upper Extremity Superficial Veins

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna	Waehringer Guertel 18-20
Germany	University Hospital of Cologne	Cologne
Germany	Schon Klinik	Dusseldorf
Italy	Azienda Ospedaliera San Carlo Borromeo	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ability to place central venous access catheter using Surfacer system	performance evaluated by procedure time measured by time to create access	Procedure
Secondary	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
Secondary	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