ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Launched by TENAXIS MEDICAL, INC. · Sep 23, 2008

Keywords

ClinConnect Summary

To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subject must meet all of the following criteria to be eligible for treatment in the Study:
• • 1. The subject must be equal or greater than 18 years old.
• • 2. The subject must be scheduled for the surgical placement of a synthetic (i.e., PTFE/Dacron) vascular graft or patch for large vessel repair/arterial reconstruction/hemodialysis access/arteriotomy.
• • 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 the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
• • 5. The subject or guardian must provide written informed consent using a form that is reviewed and approved by the IRB.
• Exclusion Criteria:
• Subjects will be excluded from the Study if any of the following criteria are met:
• • 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 transfusions.
• • 3. The subject is currently enrolled in this, or another investigational device or drug trial (IDE or IND) that has not completed the required follow-up period. Note: Extended follow-up trials for products that were investigational but are currently commercially available are not considered investigational trials.