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 range18 Years

SexALL

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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 \[\< …

What they're measuring

Time to Hemostasis

Incidence rate of device-related major complications

Trial details

NCT IDNCT00388284

SponsorVascular Solutions LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-03