ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Phase 3

Completed

• Conditions: Vascular Disease
• Interventions: Device: Gelfoam and Thrombin; Device: ArterX Surgical Sealant

• Registration Number: NCT00759681
• Lead Sponsor: Tenaxis Medical, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-23
• Study First Submitted QC: 2008-09-23
• Study First Posted: 2008-09-25
• Primary Completion: 2009-12
• Study Completion: 2010-03
• Results First Submitted: 2012-10-31
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-20
• Last Update Submitted: 2012-12-20
• Results First Posted: 2013-01-31
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Gelfoam and Thrombin	Gelfoam and Thrombin
Investigational Device	ArterX Surgical Sealant	ArterX Surgical Sealant

Primary Outcome Measures

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

Trial Locations

Locations (1)

Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States