Clinical trial NCT02234830: Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
Official title: Randomized Comparison of ExoSeal® and Angio-Seal Vascular Closure Devices: The CLOSE-UP II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: PCI
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Cordis Corporation
name: Abbott Medical Devices
First posted: 2014-09-09
Enrollment: 818
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
timeFrame: 30 days
Secondary outcomes:
measure: Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: Device failure
timeFrame: 30 minutes
measure: Vasovagal reaction until 5 minutes after end of closure procedure
timeFrame: 30 minuts
measure: Need for new onset of manual compression
timeFrame: 30 days
measure: Pain and discomfort related to the closure procedure
timeFrame: Closure procedure and 30 days
measure: Time to mobilization
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: In-hospital large groin haematoma
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 days
measure: Bleedings according to the BARC definitions
timeFrame: 30 days
measure: Major bleeding and/or bleeding necessitating blood transfusion
timeFrame: 6 months
measure: Pseudoaneurysm with indication for treatment
timeFrame: 30 days and 6 months
measure: Arteriovenous fistula
timeFrame: 30 days and 6 months
measure: Groin surgery and/or possible related vascular surgery
timeFrame: 30 days and 6 months
measure: Infection needing antibiotics
timeFrame: 30 days and 6 months
measure: Need for medical evaluation of possible closure procedure related symptom(s)
timeFrame: 30 days
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Arhus University Hospital Skejby
name: Evald H Christiansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: