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Angioplasty, Transluminal, Percutaneous CoronaryPhase 2PACS 7FNCT00533156

Plug Arterial Closure System (PACS, 7F)

A Phase 2 study testing Vascular access site closure (7F Ensure) in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, run by Cordis US Corp. at 1 site in Mexico.

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 assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard 7F introducer sheath. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Vascular access site closure (7F Ensure)
Type of treatment
Medical device
How many people
30 participants
Where
1 siteMexico
Study dates
Jul 2007to Aug 2007
Phase
Phase 2
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for a coronary diagnostic or interventional procedure
  • Able to undergo emergent vascular surgery if a complication requires it
  • 7F 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/m2
  • 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. 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

1 site in 1 country.

Mexico1 site

  • Hospital Almater

    Mexicali, Estado de Baja California, 21100

Other trials in Mexico

About this study

Official title: Feasibility Study of the 7F Ensure Medical Plug Arterial Closure System (PACS, 7F)

The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard 7F introducer sheath.

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 catheterizations using a standard 7F 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 utilizing a 6F introducer sheath, 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.

Being tested
Vascular access site closure (7F Ensure)
Keywords
Closure Device, Angiography, Angioplasty, Hemostasis, Heart Catheterization, Vascular Closure, Peripheral 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.

  • Vascular access site closure (7F Ensure)Device

What is being measured

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

  1. Time to hemostasis following vessel access site closure

    Measured: 5 minutes post procedure

  2. Time to ambulation following vessel access site closure

    Measured: Post-procedure

  3. Combined rate of closure related major adverse events at 30 days

    Measured: Through 30 days

Secondary outcomes (5)

  1. Device success (initial hemostasis within 5 minutes)

    Measured: Within 5 minutes

  2. Procedural success on day of catheterization and at 30 days (initial hemostasis by non-randomized treatment without closure related serious adverse events)

    Measured: Through 30 days

  3. Time patient is deemed eligible for hospital discharge relative to their access site closure

    Measured: Up to hospital discharge

  4. Time patient is discharged from the hospital

    Measured: Patient discharge

  5. Known events associated with vascular closure devices

    Measured: Through 30 days

Timeline

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

  1. First posted21 Sep 2007 (estimated)
  2. Study startJul 2007
  3. Study completionAug 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00533156
Sponsor's protocol ID
EMI 07-02
Acronym
PACS 7F
Status last verified
Feb 2012
First submitted
19 Sep 2007
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vascular access site closure (7F Ensure) in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, run by Cordis US Corp. at 1 site in Mexico.

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 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 following vessel access site closure (time frame: 5 minutes post procedure). 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 NCT00533156.

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 28 Feb 2012.

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