Safety and Efficacy Study Comparing Thrombin for Arterial Sealing (NCT00388284) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study Comparing Thrombin for Arterial Sealing
United States270 participantsStarted 2006-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
Exclusion criteria determined prior to procedure:
* The subject has a history of clinically severe peripheral vascular disease documented as any of the following:
* Severe claudication (walking \< 100 feet)
* Absent pulses in the affected limb
* ABI \< 0.5 at rest
* Known diameter stenosis ≥ 50% in the iliac or femoral artery on the affected side
* Prior vascular bypass surgery involving the affected femoral artery
* Prior stent placement in the vicinity of the arterial puncture site
* The subject is known to be, or suspected to be, pregnant (verified in a manner consistent with institution's standard of care), or is lactating
* The subject has a pre-existing severe non-cardiac systemic disease or pre-existing terminal illness
* The subject has had an acute myocardial infarction ≤ 72 hours before the catheterization procedure
* The subject is unable to ambulate at baseline
* The subject is known to require an extended hospitalization (e.g., subject is undergoing CABG surgery)
* The subject has a known bleeding disorder (including thrombocytopenia \[\< …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Hemostasis
2
Incidence rate of device-related major complications