NCT02234830.

Trial name or title	CLOSE‐UP II trial
Methods	Study design : randomised parallel‐assignment open‐label Country : Denmark Setting : hospital Number of centres : multi‐centre
Participants	Inclusion criteria Ability to provide valid informed signed consent PCI procedure including treatment by balloon and/or stent PCI indicated by silent ischaemia, stable angina pectoris, non‐ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) Exclusion criteria Only coronary angiography Multiple punctures Active infection Groin haematoma before the closure procedure Sheath size > 7 Fr Known pseudoaneurysm or arterio‐venous (AV) fistula in the ipsilateral groin Prior arterial surgery in abdomen and/or lower extremities Cardiogenic shock Life expectancy < 1 year Female of childbearing potential with possible pregnancy or positive pregnancy test within 7 days before index procedure, or lactating Simultaneous or planned subsequent femoral vein access Allergy to any of the components in the closure material left in the groin Puncture of same site < 30 days Peripheral artery disease patients can be included at operator's discretion except if heavy calcification is present at the access site, which at the operator's discretion precludes insertion of the VCD
Interventions	Intervention 1 : AngioSeal Intervention 2 : ExoSeal
Outcomes	Primary Incidence at 30 days of the composite endpoint of access site‐related major adverse vascular events. This includes major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery and infection needing antibiotic Secondary Time to haemostasis from removal of the sheath (AngioSeal) or insertion of the device (ExoSeal) until 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 Time to mobilisation In‐hospital large groin haematoma Bleeding according to BARC definitions Major bleeding and/or bleeding necessitating 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)
Starting date	December 2012
Contact information	hellbarg@rm.dk niels.holm@clin.au.dk
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