Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial

Aarhus University Hospital Skejby

Status: Completed

Conditions: Coronary Disease

Treatments: Device: Exoseal closure device; Device: Angioseal closure device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02234830

1-10-72-68-12

Details and patient eligibility

About

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.

Full 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 (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.

Enrollment: 818 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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818 participants in 2 patient groups

Exoseal closure device

Experimental group

Description:

Closure device for femoral artery access closure

Treatment:

Device: Exoseal closure device

Angio-Seal closure device

Active Comparator group

Description:

Closure device for femoral artery access closure

Treatment:

Device: Angioseal closure device