Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial (CLOSE-UP III)

May 7, 2019 updated by: Evald Hoej Christiansen, Aarhus University Hospital Skejby
Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.

Study Type

Interventional

Enrollment (Actual)

869

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >18 year
  • Should be able to provide valid informed signed consent
  • CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)

Exclusion Criteria:

  • Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
  • ST-Elevations Myocardial Infarction (STEMI)
  • Multiple punctures
  • Active infection
  • Groin haematoma before the closure procedure
  • Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin
  • Cardiogenic shock
  • Prior peripheral arterial surgery in abdomen or lower extremities
  • Sheat size >7 F
  • Life expectancy less than one year
  • Possible pregnancy or positive pregnancy test or breastfeeding women
  • Simultaneous or planned subsequent femoral vein access
  • Allergy to any of the components in the closure material left in the groin
  • Puncture or closure with closure device at same site < 30 days
  • Puncture or closure with manuel compression at same site < 5 days
  • Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Manuel compression
Conventional manual compression
Other: Manual compression
Conventional manual compression
EXPERIMENTAL: MynxGrip closure device
Closure device for femoral artery access closure
Device: MynxGrip
Closure device for femoral artery access closure
Other Names:
  • Closure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
Time Frame: 30 days
This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for new onset of manual compression
Time Frame: 30 days
30 days
Pseudoaneurysm with indication for treatment
Time Frame: 30 days and 6 months
30 days and 6 months
Arteriovenous fistula
Time Frame: 30 days and 6 months
30 days and 6 months
Groin surgery and/or possible related vascular surgery
Time Frame: 30 days and 6 months
30 days and 6 months
Infection needing antibiotics
Time Frame: 30 days and 6 months
30 days and 6 months
Need for medical evaluation of possible closure procedure related symptom(s)
Time Frame: 30 days
30 days
Time (min) to haemostasis
Time Frame: 30 days
From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis
30 days
Device failure
Time Frame: 30 minutes
30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Time Frame: 30 minutes
30 minutes
Pain and discomfort related to the closure procedure
Time Frame: Closure procedure and 30 days
Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort).
Closure procedure and 30 days
Time to mobilization
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
From start of closure procedure to patient is mobilised.
participants will be followed for the duration of hospital stay, an expected average of 2 days
In-hospital large groin haematoma
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge
Participants will be followed for the duration of hospital stay, an expected average of 2 days
Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions
Time Frame: 1 hour and 30 days
1 hour and 30 days
Major bleeding and/or bleeding necessitation blood transfusion
Time Frame: 30 days and 6 months
30 days and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital Skejby

Collaborators

Vingmed Danmark A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 16, 2014

Primary Completion (ACTUAL)

May 16, 2017

Study Completion (ACTUAL)

December 16, 2018

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (ESTIMATE)

September 11, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOSE-UP III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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