Status:
COMPLETED
Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Cordis US Corp.
Abbott Medical Devices
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
Detailed Description
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (stan...
Eligibility Criteria
Inclusion
- Should be able to provide valid informed signed consent
- PCI procedure including treatment by balloon and/or stent
- PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
Exclusion
- Only coronary angiography
- Multiple punctures
- Active infection
- Groin haematoma before the closure procedure
- Sheath size \> 7 French
- Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin
- Prior arterial surgery in abdomen and/or lower extremities
- Cardiogenic shock
- Life expectancy less than one year
- The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating
- Simultaneous or planned subsequent femoral vein access
- Allergy to any of the components in the closure material left in the groin
- Puncture on 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
Key Trial Info
Start Date :
December 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2017
Estimated Enrollment :
818 Patients enrolled
Trial Details
Trial ID
NCT02234830
Start Date
December 21 2012
End Date
May 14 2017
Last Update
June 1 2017
Active Locations (2)
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1
Aarhus University Hospital
Aarhus N, Denmark, 8200
2
Odense University Hospital
Odense, Denmark, 5000