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ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Sponsored by Tenaxis Medical, Inc.

About this trial

Last updated 12 years ago

Study ID

CLN-004

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 15 years ago

What is this trial about?

This is a prospective, multi-center randomized, controlled study. The study is designed to assess the safety effectiveness of the ArterX Vascular Sealant compared to the control group in the open surgical repair of large vessels using synthetic vascular grafts or patches.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status