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

Not Applicable

Completed

• Conditions: Vascular Disease
• Interventions: Device: ArterX Vascular Sealant

• Registration Number: NCT02476318
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-08
• Study Completion: 2007-11
• Status Verified: 2015-06
• Study First Submitted: 2015-06-16
• Study First Submitted QC: 2015-06-16
• Last Update Submitted: 2015-06-16
• Study First Posted: 2015-06-19
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ArterX Vascular Sealant	ArterX Vascular Sealant	-

Primary Outcome Measures

Name	Time	Method
Number of anastomoses with immediate sealing of the suture line	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.

Trial Locations

Locations (3)

Krankenhaus Dresden Friedrichstadt; 🇩🇪 Dresden, Germany

Chirugische Uni Klinikum; 🇩🇪 Ulm, Germany

Klinikum der Universitat zu Koln; 🇩🇪 Koln, Germany