Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

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 [< 100,000 platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)
• 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)
• The subject has a known allergy to bovine derived products or any other materials used in the Diagnostic Duett Pro Sealing Device
• The subject has undergone prior use of a closure device in the ipsilateral common femoral artery ≤ 6 months before the current catheterization procedure
• 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
• 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.