ArterX Safety and Efficacy Study for Cardiac Indications

Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957904
• Other study ID #: CLN-015
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: November 16, 2015
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2015
• Source: Tenaxis Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesministerium für Gesundheit
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

Device:
• ArterX Surgical Sealant

Locations

Country	Name	City	State
Germany	Krankenhaus Der Barmherzigen Bruder	Trier

Sponsors (1)

Lead Sponsor	Collaborator
Tenaxis Medical, Inc.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Skorpil J, Paraforos A, Mandak J, Cohn WE, Hajek T, Friedrich I. Effective and rapid sealing of coronary, aortic and atrial suture lines †. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):720-4; discussion 724. doi: 10.1093/icvts/ivv061. Epub 2015 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No