This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to assess antibody and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be conducted as a component of this trial with a subset of the enrolled study subjects. Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270 subjects will provide blood specimens at baseline and at the 30 day follow-up visit for evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45 subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the immunologic sub-study. The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to the study group treated with the sealing device manufactured with Thrombin JMI. The primary safety objective is to demonstrate a device-related major complication rate for the study group treated with the sealing device manufactured with Thrombin VSI that is non-inferior to the device-related major complication rate observed for the study group treated with the sealing device manufactured with Thrombin JMI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
270
The Heart and Vascualr Institute of Florida
Safety Harbor, Florida, United States
Ochsner Clinic
New Orleans, Louisiana, United States
WakeMed
Raleigh, North Carolina, United States
Mary Washington Hospital
Fredericksburg, Virginia, United States
Charleston Area Medica Center (CAMC)
Charleston, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Time to Hemostasis
Incidence rate of device-related major complications
Time to ambulation
Subject satisfaction
Procedure success
Device success
Minor complications
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