ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

NCT00759681 | Completed Phase 3 Results DMC

• 2 other identifiers: CLN-004IDE Number - G070211
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Disease

Keywords

Arterial Surgery; Open vascular Surgery; Sealant

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

Gelfoam and Thrombin

Device: Gelfoam and Thrombin

Investigational Device

EXPERIMENTAL

ArterX Surgical Sealant

Device: ArterX Surgical Sealant

Interventions

ArterX Surgical Sealant DEVICE

Apply at the suture site.

Also known as: ArterX Vascular Sealant

Investigational Device

Gelfoam and Thrombin DEVICE

Apply at the suture site.

Also known as: Gelfoam Plus

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tenaxis Medical, Inc.: lead

Study Sites (1)

Greenville Memorial Hospital

Greenville, South Carolina, 29615, United States

Location

Related 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.

  PMID: 22939276 RESULT

MeSH Terms

Conditions

Vascular Diseases

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

There were no significant trial limitations.

Results Point of Contact

• Title: David Cull, MD
• Organization: Greenville Memorial Hospital

864-455-9825

Study Officials

• David Cull, MD

  Greenville Hospital System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: January 31, 2013
• Results First Posted: January 31, 2013

Record last verified: 2012-12

Locations

US (1)