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

Tenaxis Medical

Status: Completed

Conditions: Vascular Disease

Treatments: Device: ArterX Vascular Sealant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02476318

CLN-008

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

ArterX Vascular Sealant

Experimental group

Treatment:

Device: ArterX Vascular Sealant