NCT02237430

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
869

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2018

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

September 4, 2014

Last Update Submit

May 7, 2019

Conditions

Coronary Disease

Keywords

Coronary angiography (CAG)

Outcome Measures

Primary Outcomes (1)

  • Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)

    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 Outcomes (14)

  • Time (min) to haemostasis

    30 days

  • Device failure

    30 minutes

  • Vasovagal reaction until 5 minutes after end of closure procedure

    30 minutes

  • Need for new onset of manual compression

    30 days

  • Pain and discomfort related to the closure procedure

    Closure procedure and 30 days

  • +9 more secondary outcomes

Study Arms (2)

Manuel compression

ACTIVE COMPARATOR

Conventional manual compression

Other: Manual compression

MynxGrip closure device

EXPERIMENTAL

Closure device for femoral artery access closure

Device: MynxGrip

Interventions

MynxGripDEVICE

Closure device for femoral artery access closure

Also known as: Closure device
MynxGrip closure device
Manual compressionOTHER

Conventional manual compression

Manuel compression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

  • Jakobsen L, Holm NR, Maeng M, Thim T, Kristensen SD, Mogensen LH, Christiansen EH. Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial. BMC Cardiovasc Disord. 2022 Feb 23;22(1):68. doi: 10.1186/s12872-022-02512-0.

    PMID: 35196986DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Vascular Closure Devices

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Evald H Christiansen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 11, 2014

Study Start

June 16, 2014

Primary Completion

May 16, 2017

Study Completion

December 16, 2018

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

DK(1)