Vascular Disease
Conditions
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.
Interventions
DEVICEArterX Vascular Sealant
Sponsors
Tenaxis Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed