ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial (StEPS)

Tenaxis Medical

Status and phase

Completed

Phase 3

Conditions

Vascular Disease

Treatments

Device: Gelfoam and Thrombin

Device: ArterX Surgical Sealant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00759681

CLN-004

IDE Number - G070211

Details and patient eligibility

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.

Full description

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.

Enrollment

217 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must meet all of the following criteria to be eligible for treatment in the Study:

The subject must be equal or greater than 18 years old.
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.
The subject has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure.
The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
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:

The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products.
The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions.
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.