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

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ClinicalTrials.gov Identifier: NCT02476318
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Tenaxis Medical, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vascular Disease Device: ArterX Vascular Sealant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Performance of ArterX™ Vascular Sealant in Sealing Synthetic Arterial Grafts
Study Start Date : June 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
Experimental: ArterX Vascular Sealant Device: ArterX Vascular Sealant



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476318


Locations
Germany
Krankenhaus Dresden Friedrichstadt
Dresden, Germany
Klinikum der Universitat zu Koln
Koln, Germany
Chirugische Uni Klinikum
Ulm, Germany
Sponsors and Collaborators
Tenaxis Medical, Inc.
Investigators
Principal Investigator: Hans J Florek, MD Krankenhaus Dresden Friedrichstadt Dresden, Germany

Responsible Party: Tenaxis Medical, Inc.
ClinicalTrials.gov Identifier: NCT02476318     History of Changes
Other Study ID Numbers: CLN-008
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases