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.
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.
