Surfacer System to Facilitate Access in Venous Occlusions

NCT02875899 | Completed DMC

• 1 other identifier: CP0002
• Study Type: observational
• Target: 30
• Locations: 3 countries
• Sites: 4

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.

Conditions

Chronic Venous Thrombosis; Venous Thrombosis Upper Extremity; Venous Thrombosis Upper Extremity Superficial Veins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Ability to place central venous access catheter using Surfacer system

  Procedure

• Surfacer system advancement of the exit wire outside the vein

  procedure

• Insertion of a standard central venous access catheter to deliver fluid or pharmacological agents

  procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients requiring central venous access for: * dialysis * chemotherapy nutrition * delivery of any pharmacological therapy

You may qualify if:

• patients with limited or diminishing upper body venous access
• pathology impeding standard access methods
• signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead

Study Sites (4)

University of Vienna

Vienna, Waehringer Guertel 18-20, A 1090, Austria

Location

University Hospital of Cologne

Cologne, D-50937, Germany

Location

Schon Klinik

Düsseldorf, 40549, Germany

Location

Azienda Ospedaliera San Carlo Borromeo

Milan, 20153, Italy

Location

Related Publications (3)

• 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.

  PMID: 21237290 BACKGROUND

• 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.

  PMID: 24593804 BACKGROUND

• 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.

  PMID: 19595350 BACKGROUND

Study Officials

• Laura Minarsch, RT

  Bluegrass Vascular

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 23, 2016
• Study Start: February 7, 2017
• Primary Completion: September 20, 2018
• Study Completion: October 4, 2018
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

IT (1); AU (1); DE (2)