Hemostasis of Arterial Punctures
Conditions
Keywords
hemostasis, arterial sealing
Brief summary
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.
Interventions
DEVICEArterial Sealing
Sponsors
Vascular Solutions LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is 18 years of age or older * The subject is undergoing a diagnostic or interventional endovascular procedure via a retrograde femoral arterial access * The subject is willing and able to provide appropriate informed consent * The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Hemostasis | — |
| Incidence rate of device-related major complications | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success | — |
| Time to ambulation | — |
| Minor complications | — |
| Device success | — |
| Subject satisfaction | — |
Countries
United States
Outcome results
None listed