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Status:

COMPLETED

Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

Lead Sponsor:

Vascular Solutions LLC

Conditions:

Hemostasis of Arterial Punctures

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2006

Trial Type :

INTERVENTIONAL

End Date :

March 1 2007

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT00388284

Start Date

August 1 2006

End Date

March 1 2007

Last Update

December 9 2015

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

The Heart and Vascualr Institute of Florida

Safety Harbor, Florida, United States, 34695

2

Ochsner Clinic

New Orleans, Louisiana, United States, 70121

3

WakeMed

Raleigh, North Carolina, United States, 27610

4

Mary Washington Hospital

Fredericksburg, Virginia, United States, 22401