ArterX Safety and Efficacy Study for Cardiac Indications

Study Overview
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Brief Summary
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The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.

Official Title
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Prospective, Multi-Center, Open-Label, Post-Market ArterX® Safety and Efficacy Study Protocol for Cardiac Indications

Conditions
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Vascular Disease

Intervention / Treatment
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* Device: ArterX Surgical Sealant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study. The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee. The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol. The subject is determined by the surgeon to be at risk for poor hemostasis. Exclusion Criteria: Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up. Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days. Subject is pregnant, may become pregnant or is currently breast feeding -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ArterX Surgical Sealant<br> | Device: ArterX Surgical Sealant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with immediate sealing of suture/staple line | Immediate sealing of the suture/staple line at point of use upon release of the clamps, as evidenced by an absence of clinically significant bleeding as determined by physician investigator in procedures completed using the ArterX device. | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ArterX, surgical sealant