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

Primary Purpose

Vascular Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

ArterX Surgical Sealant

Gelfoam and Thrombin

About this trial

This is an interventional treatment trial for Vascular Disease focused on measuring Arterial Surgery, Open vascular Surgery, Sealant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Greenville Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Investigational Device

Arm Description

Gelfoam and Thrombin

ArterX Surgical Sealant

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00759681

First Posted

September 23, 2008

Last Updated

December 20, 2012

Sponsor

Tenaxis Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00759681

Brief Title

ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

Acronym

StEPS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tenaxis Medical, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Disease

Keywords

Arterial Surgery, Open vascular Surgery, Sealant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

217 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Gelfoam and Thrombin

Arm Title

Investigational Device

Arm Type

Experimental

Arm Description

ArterX Surgical Sealant

Intervention Type

Device

Intervention Name(s)

ArterX Surgical Sealant

Other Intervention Name(s)

ArterX Vascular Sealant

Intervention Description

Apply at the suture site.

Intervention Type

Device

Intervention Name(s)

Gelfoam and Thrombin

Other Intervention Name(s)

Gelfoam Plus

Intervention Description

Apply at the suture site.

Primary Outcome Measure Information:

Title

Immediate Sealing Evidenced by no Bleeding on Clamp Release.

Description

The immediate sealing evidenced by no bleeding on clamp release was measured at time of surgery

Time Frame

Immediate at time of surgery

Title

Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response

Description

The Primary Safety Endpoint Will be the Cumulative Incidence of Significant Bleeding, Infection, Neurological Deficit or Inflammatory/Immune Allergic Response Through 6 Weeks.

Time Frame

Treatment through 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Cull, MD

Organizational Affiliation

Greenville Hospital System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Greenville Memorial Hospital

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22939276

Citation

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.

Results Reference

result

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ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

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