Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Coronary angiography (CAG)
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Vingmed Danmark A/S
First posted: 2014-09-11
Enrollment: 869
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)
timeFrame: 30 days
Secondary outcomes:
measure: Time (min) to haemostasis
timeFrame: 30 days
measure: Device failure
timeFrame: 30 minutes
measure: Vasovagal reaction until 5 minutes after end of closure procedure
timeFrame: 30 minutes
measure: Need for new onset of manual compression
timeFrame: 30 days
measure: Pain and discomfort related to the closure procedure
timeFrame: Closure procedure and 30 days
measure: Time to mobilization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: In-hospital large groin haematoma
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions
timeFrame: 1 hour and 30 days
measure: Major bleeding and/or bleeding necessitation blood transfusion
timeFrame: 30 days and 6 months
measure: Pseudoaneurysm with indication for treatment
timeFrame: 30 days and 6 months
measure: Arteriovenous fistula
timeFrame: 30 days and 6 months
measure: Groin surgery and/or possible related vascular surgery
timeFrame: 30 days and 6 months
measure: Infection needing antibiotics
timeFrame: 30 days and 6 months
measure: Need for medical evaluation of possible closure procedure related symptom(s)
timeFrame: 30 days
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.