Safety and Efficacy Study Comparing Thrombin for Arterial Sealing
- Conditions
- Hemostasis of Arterial Punctures
- Registration Number
- NCT00388284
- Lead Sponsor
- Vascular Solutions LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
- 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 determined prior to procedure:
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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)
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The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)
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The subject is receiving Coumadin/warfarin therapy and has an INR > 2.0 on the day of, or the day before the study procedure. (INR of > 2.0 should not result in a dose change prior to the study procedure. If dosage changed, test should be repeated prior to the procedure)
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The subject has a known allergy to bovine derived products or any other materials used in the Diagnostic Duett Pro Sealing Device
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The subject has undergone prior use of a closure device in the ipsilateral common femoral artery ≤ 6 months before the current catheterization procedure
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The subject has undergone prior use of manual compression for closure in the ipsilateral common femoral artery ≤ 6 weeks before the current catheterization procedure
-
The subject has undergone current, recent, or prior use of an intra-aortic balloon pump through the existing arterial puncture site
-
The subject is unavailable for follow-up
-
The subject is currently participating in another investigational device or drug trial
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The subject has previously participated in this trial (Protocol 0106)
Exclusion criteria to be determined during the procedure:
- The subject has an antegrade puncture
- The subject's arterial introducer sheath is <5F or > 9F or longer than 15.2 cm in overall length
- The subject has a suspected posterior femoral arterial wall puncture or puncture distal to the common femoral artery bifurcation
- The subject's common femoral artery diameter is estimated to be < 6 mm via angiogram
- The subject has tortuous vascular anatomy with greater than 90o bends on femoral angiogram
- The subject is severely hypertensive (defined as systolic BP > 180 mmHg or diastolic BP > 110 mmHg)
- The subject has experienced hemodynamic instability, defined as systolic blood pressure < 90 mmHg or cardiogenic shock, during or immediately post-procedure
- The subject has been anticoagulated with unfractionated heparin and has an ACT of > 300 seconds at completion of the antecedent procedure
- The subject is anticipated to continue dosing of heparin or anti-coagulant therapy (except any approved GPIIb/IIIa platelet receptor blocker) ≤ 6 hours following completion of the interventional or diagnostic procedure
- The subject has received thrombolytic therapy (e.g., streptokinase, urokinase, or t-PA) ≤ 24 hours prior to the catheterization procedure
- The subject has a large hematoma (≥ 6cm in diameter) present prior to vascular sealing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Time to Hemostasis Incidence rate of device-related major complications
- Secondary Outcome Measures
Name Time Method Procedure success Device success Minor complications Time to ambulation Subject satisfaction
Trial Locations
- Locations (6)
The Heart and Vascualr Institute of Florida
🇺🇸Safety Harbor, Florida, United States
Charleston Area Medica Center (CAMC)
🇺🇸Charleston, West Virginia, United States
WakeMed
🇺🇸Raleigh, North Carolina, United States
Mary Washington Hospital
🇺🇸Fredericksburg, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States