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OpenTrials
Completed

NCT Number: NCT02476318

A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts

A prospective, multi-center study to evaluate the safety and performance outcomes of the ArterX Vascular Sealant when used for prophylactic sealing of suture lines at the anastomosis between native vessel and synthetic vascular grafts.

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Key information

Conditions

Vascular Disease Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum der Universitat zu Koln, Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject must be ≥ 18 years old
  • The subject must be scheduled for surgical placement of a synthetic graft for large vessel repair/ arterial reconstruction/ hemodialysis access.
  • The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
  • The subject is willing and able to be contacted for minimum of 6 weeks follow up.
  • The subject or guardian must provide written informed consent using a form that is reviewed and approved by the Ethics Committee.

Exclusion criteria

  • The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
  • The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusion.
  • The subject is currently enrolled in this, or another investigational device or drug trail that has not completed the required follow-up period.
  • ArterX Vascular Sealant should not be used in patients who have exhibited an allergic reaction to materials of shellfish or bovine origin.

Treatment and study plan

ArterX Vascular Sealant

Device

Primary outcomes

  1. Number of anastomoses with immediate sealing of the suture line

    Time frame: Intraoperative

    Immediate suture line sealing on clamp removal, as evidenced by a lack of clinically significant bleeding. A minimum of 50% of the anastomoses were expected to be sealed immediately.

Sponsors and collaborators

Lead sponsor

Tenaxis Medical, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 19, 2015
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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