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

Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476318
• Other study ID #: CLN-008
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: June 16, 2015
• Start date: June 2007
• Est. completion date: November 2007

Study information

• Verified date: June 2015
• Source: Tenaxis Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Freiburg Central Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

Device:
• ArterX Vascular Sealant

Locations

Country	Name	City	State
Germany	Krankenhaus Dresden Friedrichstadt	Dresden
Germany	Klinikum der Universitat zu Koln	Koln
Germany	Chirugische Uni Klinikum	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Tenaxis Medical, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of anastomoses with immediate sealing of the suture line	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.	Intraoperative	No