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

NCT ID: NCT02234830

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 818 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-21
• Study Completion Date: 2017-05-14

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

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exoseal closure device

Closure device for femoral artery access closure

Group Type: EXPERIMENTAL

Exoseal closure device

Intervention Type: DEVICE

Closure device for femoral artery access closure

Angio-Seal closure device

Closure device for femoral artery access closure

Group Type: ACTIVE_COMPARATOR

Angioseal closure device

Intervention Type: DEVICE

Closure device for femoral artery access closure

Interventions

Exoseal closure device

Closure device for femoral artery access closure

Intervention Type: DEVICE

Angioseal closure device

Closure device for femoral artery access closure

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Evald Hoej Christiansen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evald H Christiansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Arhus University Hospital Skejby

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-68-12

Identifier Type: -

Identifier Source: org_study_id