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Surgical WoundCloserNCT02136004

The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

A study testing Closer VSS in people with Surgical Wound, run by Rex Medical at 12 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 objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Surgical Wound
What is being tested?
Closer VSS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
12 sitesUnited States
Study dates
May 2014to Feb 2015
Phase
Interventional
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-Op Inclusion Criteria:
  • 1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath.
  • -

Who cannot join

  • Pre-Operative Exclusion Criteria:
  • - Significant bleeding diatheses or coagulopathy
  • - Planned endovascular or surgical procedures within next 30 days
  • - Planned ipsilateral femoral arteriotomy within next 90 days
  • - Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication
  • - Previous vessel closure device used in ipsilateral groin within the past 90 days
Show all 18Show fewer
  • - Previous vascular surgery or repair in the vicinity of the target access site
  • - Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days
  • - Existing nerve damage in ipsilateral limb
  • - Extreme morbid obesity (BMI > 4 kg/m2)
  • Intra-operative Exclusion Criteria:
  • - Use of a procedural sheath that is < 5 Fr or > 7 Fr
  • - Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure
  • - Placement of an ipsilateral venous sheath for procedure
  • - Procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
  • - In subjects receiving unfractionated heparin, an ACT > 350 seconds, or > 250 seconds in the presence of a GP IIb/IIIa inhibitor
  • - Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure
  • - Systemic hypertension (SBP > 180 mmHg) or hypotension (SBP < 90 mmHg) just prior to enrollment

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Geisinger Health Center

    Danville, Pennsylvania, 17822

  • North Ohio Research

    Elyria, Ohio, 44035

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Lafayette General Medical Center/Cardiovascular Institute of the South

    Lafayette, Louisiana, 70503

  • New York Presbyterian Hospital

    New York, New York, 10065

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Geisinger Health Center

    Wilkes-Barre, Pennsylvania, 18711

  • Pinnacle Health

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

About this study

Official title: The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures

The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.

Read the detailed description

The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.

Conditions
Surgical Wound
Being tested
Closer VSS
Keywords
arteriotomy, vessel closure, femoral access site
Medical subject headings
Surgical Wound

What participants receive

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

  • Closer VSSDevice

    Also called Rex Medical Closer TM Vascular Sealing System (VSS)

    At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.

Study groups in NCT02136004
Study groupRoleWhat they receive
Closer VSSExperimentalRex Medical Closer Vascular Sealing System to close femoral arteriotomy
Receives: Device: Closer VSS

What is being measured

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

  1. Time to Hemostasis

    Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis

    Measured: procedural, usually within 15 minutes of enrollment

  2. Rate of Combined Major Access Site Closure-related Complications

    Primary safety endpoint - rate of combined major access site closure-related complications

    Measured: Through 30 days +/- 7 days

Secondary outcomes (6)

  1. Time to Ambulation

    Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site

    Measured: prior to hospital discharge, usually within 24 hours

  2. Time to Discharge Eligibility

    Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)

    Measured: prior to hospital discharge, usually within 24 hours

  3. Time to Hospital Discharge

    Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward

    Measured: through hospital discharge, usually within 24 hours

  4. Device Success

    Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression

    Measured: procedural, usually within 15 minutes of enrollment

  5. Rate of Combined Minor Access Site Closure-related Complications

    Secondary safety endpoint - rate of combined minor access site closure-related complications

    Measured: through 30 +/- 7 days

  6. Procedure Success

    Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days

    Measured: through 30 days +/- 7 days

Timeline

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

  1. First posted12 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02136004
Sponsor's protocol ID
REX-US-2027-001
Acronym
Closer
Status last verified
Sep 2017
First submitted
7 May 2014
Last updated
27 Oct 2017
Data monitoring committee
Yes
Individual data sharing
Yes: After multi-center manuscript is published.

Questions about this trial

What is this clinical trial studying?

A study testing Closer VSS in people with Surgical Wound, run by Rex Medical at 12 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 3 inclusion and 18 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2016). 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 (time frame: procedural, usually within 15 minutes of enrollment). 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 NCT02136004.

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 27 Oct 2017.

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