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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
869
Closure device for femoral artery access closure
Conventional manual compression
Aarhus University Hospital
Aarhus N, Denmark
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.
Time frame: 30 days
Time (min) to haemostasis
From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis
Time frame: 30 days
Device failure
Time frame: 30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Time frame: 30 minutes
Need for new onset of manual compression
Time frame: 30 days
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 frame: Closure procedure and 30 days
Time to mobilization
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
In-hospital large groin haematoma
Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge
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Time frame: 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
Major bleeding and/or bleeding necessitation blood transfusion
Time frame: 30 days and 6 months
Pseudoaneurysm with indication for treatment
Time frame: 30 days and 6 months
Arteriovenous fistula
Time frame: 30 days and 6 months
Groin surgery and/or possible related vascular surgery
Time frame: 30 days and 6 months
Infection needing antibiotics
Time frame: 30 days and 6 months
Need for medical evaluation of possible closure procedure related symptom(s)
Time frame: 30 days