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

Aarhus University Hospital Skejby

Status: Completed

Conditions: Coronary Disease

Treatments: Device: MynxGrip; Other: Manual compression

Study type: Interventional

Funder types: Other

Identifiers

NCT02237430

CLOSE-UP III

Details and patient eligibility

About

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.

Full 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.

Enrollment: 869 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

869 participants in 2 patient groups

Manuel compression

Active Comparator group

Description:

Conventional manual compression

Treatment:

Other: Manual compression

MynxGrip closure device

Experimental group

Description:

Closure device for femoral artery access closure

Treatment:

Device: MynxGrip