ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Vascular Disease Clinical Trial

— StEPS  

Official title:

A Prospective, Multi-center, Randomized Study to Evaluate the Safety and Efficacy of ArterX Vascular Sealant.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759681
• Other study ID #: CLN-004
• Secondary ID: IDE Number - G07
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: December 20, 2012
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2012
• Source: Tenaxis Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

Device:
• ArterX Surgical Sealant
Apply at the suture site.
• Gelfoam and Thrombin
Apply at the suture site.

Locations

Country	Name	City	State
United States	Greenville Memorial Hospital	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Tenaxis Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stone WM, Cull DL, Money SR. A randomized prospective multicenter trial of a novel vascular sealant. Ann Vasc Surg. 2012 Nov;26(8):1077-84. doi: 10.1016/j.avsg.2012.02.013. Epub 2012 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate Sealing Evidenced by no Bleeding on Clamp Release.	The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery	Immediate at time of surgery	No
Primary	Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response	The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.	Treatment through 6 weeks	Yes