Status:
TERMINATED
Study to Evaluate Safety & Effectiveness of Vascular Sealant System
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Detailed Description
Vascular surgery encompasses a wide range of surgical procedures. In these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. Bleeding at the suture...
Eligibility Criteria
Inclusion
- Subject was \> 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 was 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
Exclusion
- Subject had a known local or systemic infection. Subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count \< 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR \> 1.5. Subject was participating in a clinical trial that requires treatment with another investigational device or drug. Subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. Subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. The investigator determined that the subject should not be included in the study for reason(s) not already specified
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00439309
Start Date
April 1 2007
End Date
May 1 2008
Last Update
September 7 2017
Active Locations (1)
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1
Confluent Surgical, Inc.
Waltham, Massachusetts, United States, 02451