Status:
TERMINATED
Vascular Sealant Study
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Arteriovenous Access Grafts or Extra-anatomic and Infra-inguinal Grafts
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 reco...
Eligibility Criteria
Inclusion
- Preoperative
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00618358
Start Date
March 1 2007
Last Update
March 27 2015
Active Locations (1)
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1
Georgetown University
Washington D.C., District of Columbia, United States, 20007