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Completed

NCT Number: NCT02237430

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

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MynxGrip

Device

Closure device for femoral artery access closure

Other names: Closure device

Manual compression

Other

Conventional manual compression

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time (min) to haemostasis

    Time frame: 30 days

    From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis

  2. Device failure

    Time frame: 30 minutes

  3. Vasovagal reaction until 5 minutes after end of closure procedure

    Time frame: 30 minutes

  4. Need for new onset of manual compression

    Time frame: 30 days

  5. 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).

  6. 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.

  7. 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

  8. Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions

    Time frame: 1 hour and 30 days

  9. Major bleeding and/or bleeding necessitation blood transfusion

    Time frame: 30 days and 6 months

  10. Pseudoaneurysm with indication for treatment

    Time frame: 30 days and 6 months

  11. Arteriovenous fistula

    Time frame: 30 days and 6 months

  12. Groin surgery and/or possible related vascular surgery

    Time frame: 30 days and 6 months

  13. Infection needing antibiotics

    Time frame: 30 days and 6 months

  14. Need for medical evaluation of possible closure procedure related symptom(s)

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Vingmed Danmark A/S

Registry information

Acronym: CLOSE-UP III

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 11, 2014
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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