Coronary Disease
Conditions
Keywords
Coronary angiography (CAG)
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.
Interventions
DEVICEMynxGrip
Closure device for femoral artery access closure
OTHERManual compression
Conventional manual compression
Sponsors
Vingmed Danmark A/S
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort). |
| Time to mobilization | 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. |
| In-hospital large groin haematoma | 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 |
| Time (min) to haemostasis | 30 days | From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis |
| Major bleeding and/or bleeding necessitation blood transfusion | 30 days and 6 months | — |
| Pseudoaneurysm with indication for treatment | 30 days and 6 months | — |
| Arteriovenous fistula | 30 days and 6 months | — |
| Groin surgery and/or possible related vascular surgery | 30 days and 6 months | — |
| Infection needing antibiotics | 30 days and 6 months | — |
| Need for medical evaluation of possible closure procedure related symptom(s) | 30 days | — |
| Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions | 1 hour and 30 days | — |
Countries
Denmark
Outcome results
None listed