Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

Comparative Analysis of Thrombin Utilized in Endovascular Procedures of the Femoral Artery - CEASE Study

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.

Study Overview

• Status: Completed
• Conditions: Hemostasis of Arterial Punctures
• Intervention / Treatment: Device: Arterial Sealing

• Study Type: Interventional
• Enrollment: 270
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to Hemostasis
Incidence rate of device-related major complications

Secondary Outcome Measures

Outcome Measure
Minor complications
Subject satisfaction
Time to ambulation
Procedure success
Device success

Collaborators and Investigators

• Sponsor: Vascular Solutions LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: October 11, 2006
• First Submitted That Met QC Criteria: October 13, 2006
• First Posted (Estimate): October 16, 2006

Study Record Updates

• Last Update Posted (Estimate): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 7, 2015
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: hemostasis; arterial sealing
• Other Study ID Numbers: 0106