Study to Evaluate Safety & Effectiveness of Vascular Sealant System
Stopped early · Not applicable
Conditions studied: Peripheral Vascular Disease
In brief
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Key facts
- Study ID
- NCT00439309
- Run by
- Integra LifeSciences Corporation
- People needed
- 69
- Starts
- 2007-04-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2017-09-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Confluent Surgical, Inc. — Waltham, Massachusetts, United States
Full record on ClinicalTrials.gov
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