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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)

Primary Purpose

Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MynxGrip
Manual compression
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Coronary angiography (CAG)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manuel compression

MynxGrip closure device

Arm Description

Conventional manual compression

Closure device for femoral artery access closure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2014
Last Updated
May 7, 2019
Sponsor
Aarhus University Hospital Skejby
Collaborators
Vingmed Danmark A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02237430
Brief Title
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
Acronym
CLOSE-UP III
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 16, 2014 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
December 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Vingmed Danmark A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Coronary angiography (CAG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
869 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evald H Christiansen, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
35196986
Citation
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.
Results Reference
derived

Learn more about this trial

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

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