Status:
COMPLETED
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
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Vingmed Danmark A/S
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 endp...
Eligibility Criteria
Inclusion
- \>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
- 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
Key Trial Info
Start Date :
June 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2018
Estimated Enrollment :
869 Patients enrolled
Trial Details
Trial ID
NCT02237430
Start Date
June 16 2014
End Date
December 16 2018
Last Update
May 8 2019
Active Locations (1)
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1
Aarhus University Hospital
Aarhus N, Denmark, 8200