Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

This study has been completed.
Sponsor:
Information provided by:
Vascular Solutions, Inc
ClinicalTrials.gov Identifier:
NCT00388284
First received: October 11, 2006
Last updated: February 22, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Hemostasis of Arterial Punctures
Device: Arterial Sealing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparative Analysis of Thrombin Utilized in Endovascular Procedures of the Femoral Artery - CEASE Study

Resource links provided by NLM:


Further study details as provided by Vascular Solutions, Inc:

Primary Outcome Measures:
  • Time to Hemostasis
  • Incidence rate of device-related major complications

Secondary Outcome Measures:
  • Time to ambulation
  • Subject satisfaction
  • Procedure success
  • Device success
  • Minor complications

Estimated Enrollment: 270
Study Start Date: August 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388284

Locations
United States, Florida
The Heart and Vascualr Institute of Florida
Safety Harbor, Florida, United States, 34695
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, North Carolina
WakeMed
Raleigh, North Carolina, United States, 27610
United States, Virginia
Mary Washington Hospital
Fredericksburg, Virginia, United States, 22401
United States, West Virginia
Charleston Area Medica Center (CAMC)
Charleston, West Virginia, United States, 25304
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Vascular Solutions, Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00388284     History of Changes
Other Study ID Numbers: 0106
Study First Received: October 11, 2006
Last Updated: February 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Vascular Solutions, Inc:
hemostasis
arterial sealing

ClinicalTrials.gov processed this record on August 21, 2014