Vascular Sealant Study (VSS)

March 26, 2015 updated by: Georgetown University

A Prospective, Randomized, Multi-Center, Two Arm Study to Evaluate the Safety and Effectiveness of the Vascular Sealant System Compared With Gelfoam/Thrombin for Control of Anastomosis Suture Line Bleeding in Patients Undergoing Vascular Reconstructive Surgery With PTFE Grafts

Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures).

Study Design: The study is a multi-center, prospective, randomized controlled clinical trial that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n =151) will be randomized at a 3:1 ratio to receive either the investigational treatment (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will undergo preoperative screening to determine eligibility and will be evaluated intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to monitor for hematologic disturbances, hemorrhagic events, wound complications and other potential acute post-operative adverse events.

Up to ten (10) investigational sites will participate in the study. Enrollment is expected to take approximately 8 months for an anticipated duration of the clinical investigation of approximately 9 to 10 months.

The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and arteriovenous access procedures).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • District of columbia, District of Columbia, United States, 20007
        • Georgetown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Preoperative Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the study:

  • > 18 years of age
  • Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass and primary and secondary arteriovenous access procedures
  • Subject is willing and able to comply with all aspects of the treatment and evaluation schedule
  • Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Preoperative Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:

  • Subject has a known local or systemic infection
  • Subjects with known coagulapathies including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR > 1.5
  • Subject is participating in a clinical trial that requires treatment with another investigational device or drug
  • Subject is lactating or pregnant, or does not agree to use contraception for the duration of the study
  • Subject has a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin
  • The investigator determines that the subject should not be included in the study for reason(s) not already specified

Intraoperative Inclusion Criteria: Subjects must meet the following intraoperative inclusion criteria to be eligible for randomization:

• Suture line leaks (bleeding) confirmed prior to randomization.

Intraoperative Exclusion Criteria: Subjects who meet any of the following intraoperative exclusion criteria are considered screening failures and are not eligible to be randomized:

  • Incidental finding of any of the preoperative exclusion criteria
  • Subject has obvious contamination or a concurrent systemic infection
  • Investigator determines that participation in the study may jeopardize the safety or welfare of the subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vascular Sealant)
Device: Vascular Sealant System
The Vascular Sealant System is intended for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Active Comparator: Gelfoam/Thrombin
Other: Gelfoam/Thrombin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: David Deaton, MD, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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