Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

Vascular Solutions

Status and phase

Completed

Phase 3

Conditions

Hemostasis of Arterial Punctures

Treatments

Device: Arterial Sealing

Study type

Interventional

Funder types

Industry

Identifiers

NCT00388284

0106

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.