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Hemostasis of Arterial PuncturesPhase 3NCT00388284

Safety and Efficacy Study Comparing Thrombin for Arterial Sealing

A Phase 3 study testing Arterial Sealing in people with Hemostasis of Arterial Punctures, run by Vascular Solutions LLC at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duett Pro manufactured… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemostasis of Arterial Punctures
What is being tested?
Arterial Sealing
Type of treatment
Medical device
How many people
270 participants
Where
6 sitesUnited States
Study dates
Aug 2006to Mar 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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)
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Charleston Area Medica Center (CAMC)

    Charleston, West Virginia, 25304

  • Mary Washington Hospital

    Fredericksburg, Virginia, 22401

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • WakeMed

    Raleigh, North Carolina, 27610

  • The Heart and Vascualr Institute of Florida

    Safety Harbor, Florida, 34695

Other trials in United States

About this study

Official title: 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.

Read more

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.

Being tested
Arterial Sealing
Keywords
hemostasis, arterial sealing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arterial SealingDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Hemostasis

  2. Incidence rate of device-related major complications

Secondary outcomes (5)

  1. Time to ambulation

  2. Subject satisfaction

  3. Procedure success

  4. Device success

  5. Minor complications

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
270 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388284
Sponsor's protocol ID
0106
Status last verified
Feb 2008
First submitted
11 Oct 2006
Last updated
9 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Arterial Sealing in people with Hemostasis of Arterial Punctures, run by Vascular Solutions LLC at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Hemostasis. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.

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