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Angioplasty, Transluminal, Percutaneous CoronaryPhase 3NCT00345631

Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

A Phase 3 study testing Manual Compression and Vascular Closure Device in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, run by Cordis US Corp. at 17 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

The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Manual Compression and Vascular Closure Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
488 participants
Where
17 sitesUnited States
Study dates
Feb 2007to Sep 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for a coronary or peripheral diagnostic or interventional procedure
  • Able to undergo emergent vascular surgery if a complication requires it
  • 6F arterial puncture located in the common femoral artery
  • Femoral artery has a lumen diameter of at least 5 mm

Who cannot join

  • Arterial puncture in the femoral artery of both legs
  • Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization
  • Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders
  • Acute ST-elevation myocardial infarction within 48 hours prior to catheterization
  • Uncontrolled hypertension at time of vessel closure
  • Elevated Activated Clotting Time at time of vessel closure
Show all 28Show fewer
  • Ineligible for in-catheterization lab introducer sheath removal
  • Concurrent participation in another investigational device or drug trial
  • Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization
  • Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure
  • Prior femoral vascular surgery or vascular graft in region of access site
  • Femoral artery is tortuous or requires an introducer sheath longer than 11 cm
  • Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site that would interfere with the operation of the experimental device
  • Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
  • Antegrade vascular puncture
  • Body Mass Index over 40 kg/m^2
  • Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse
  • Femoral artery diameter stenosis exceeding 50%
  • Pre-existing severe non-cardiac systemic disease or terminal illness
  • Planned arterial access at the same access site within 30 days of catheterization
  • Extended hospitalization (e.g. Coronary Artery Bypass Graft (CABG) surgery)
  • Pre-existing systemic or cutaneous infection
  • Prior use of an intra-aortic balloon pump through the arterial access site
  • Cardiogenic shock during or immediately following the catheterization
  • Patient is unable to ambulate at baseline
  • Patient is known or suspected to be pregnant or is lactating
  • Patient is unavailable for follow-up
  • Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Cooper Health Systems

    Camden, New Jersey, 08103

  • Morton Plant Hosptial

    Clearwater, Florida, 33756

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44122

  • Baylor Research Institute

    Dallas, Texas, 75226

  • The Care Group

    Indianapolis, Indiana, 46290

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • New York Presbyterian Hospital - Cornell Medical College of Cornell University

    New York, New York, 10021

  • Hahnemann Hospital

    Philadelphia, Pennsylvania, 19102

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Wake Heart Research

    Raleigh, North Carolina, 27610

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Sutter Memorial Hospital

    Sacramento, California, 95819

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Swedish Medical Center

    Seattle, Washington, 98117

  • Washington University School of Medicine at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94305-5218

  • Moffitt Heart & Vascular Group

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

Official title: ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial

The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.

Read the detailed description

Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular complications. Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression or the deployment of a vascular closure device. Manual compression is time consuming for the health-care provider, and painful for the patient. In addition, prolonged periods of immobilization and bed rest may be required. Vascular closure devices have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.

The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site closure in patients who have undergone coronary or peripheral diagnostic or interventional procedure using a standard 6F introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery system. The plug delivery system is designed to position the bio-absorbable plug to the extravascular surface of the femoral artery access site, facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients, which demonstrated that: (1) the device could be used to successfully obtain rapid hemostasis and early ambulation in patients undergoing catheterization procedures; and (2) the low incidence and relatively minor nature of the observed closure related complications suggests that the device is safe for its intended purpose.

The ECLIPSE Trial is designed to evaluate the safety and effectiveness of the Ensure Medical VCD in comparison to standard manual compression. Patients will be randomly assigned to have their arterial access site closed using either manual compression or the VCD. The principal comparisons of the two closure techniques will include:

  • Time required to obtain hemostasis of the vascular access site
  • Time required for the patient to ambulate after their catheterization
  • Frequency of occurrence of serious closure-related complications
Being tested
Manual Compression, Vascular Closure Device
Keywords
Closure Device, Angiography, Angioplasty, Hemostasis, Heart Catheterization, Peripheral Angiography, Femoral Closure, Vascular Closure, Coronary Angiography
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Manual CompressionOther

    Manual compression

  • Vascular Closure DeviceDevice

    Also called Exoseal

    Investigational vascular closure device

Study groups in NCT00345631
Study groupRoleWhat they receive
Manual CompressionActive comparatorManual compression (MC)
Receives: Other: Manual Compression
Vascular Closure DeviceExperimentalVascular Closure Device (VCD)
Receives: Device: Vascular Closure Device

What is being measured

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

  1. Time to Hemostasis (TTH)

    Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.

    Measured: From when the introducer sheath was removed to the time hemostasis was first observed

  2. Time to Ambulation (TTA)

    Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.

    Measured: From when the introducer sheath was removed to 30 days post-procedure

  3. Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure

    Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.

    Measured: From post-procedure to 30 days follow up

Secondary outcomes (6)

  1. Time to Eligibility for Hospital Discharge

    Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient's physician.

    Measured: From introducer sheath removal to hospital discharge, up to 284 hours

  2. Time to Hospital Discharge

    Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge

    Measured: From introducer sheath removal to patient discharge

  3. Time to Device Deployment, up to 5 Minutes

    Time to device deployment is defined as from the time device inserted to the time sheath removed

    Measured: From device inserted to introducer sheath removal

  4. Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure

    Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.

    Measured: Within 5 minutes post-procedure

  5. Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure

    Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint's closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.

    Measured: From catheterization procedure to 30 day post-procedure follow up

  6. Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events

    Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse

    Measured: From end of vessel closure procedure to 30 days post-procedure

Timeline

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

  1. First posted28 Jun 2006 (estimated)
  2. Study startFeb 2007
  3. Study completionSep 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
Parallel groups
Masking
None (open label)
Enrolment
488 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00345631
Sponsor's protocol ID
EM0501
Status last verified
May 2012
First submitted
26 Jun 2006
Last updated
1 Jun 2012
Data monitoring committee
Yes

Publications

  • Wong SC, Bachinsky W, Cambier P, Stoler R, Aji J, Rogers JH, Hermiller J, Nair R, Hutman H, Wang H; ECLIPSE Trial Investigators. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009 Aug;2(8):785-93. doi: 10.1016/j.jcin.2009.06.006.

    PubMed 19695549

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Manual Compression and Vascular Closure Device in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, run by Cordis US Corp. at 17 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 28 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 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

Yes. Results are posted in the registry (first posted 19 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (TTH) (time frame: From when the introducer sheath was removed to the time hemostasis was first observed). The study lists 3 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 NCT00345631, which also lists 1 linked publication.

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 1 Jun 2012.

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