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

Coronary Disease Clinical Trial

— CLOSE-UP II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234830
• Other study ID #: 1-10-72-68-12
• Status: Completed
• Phase: N/A
• First received: June 6, 2014
• Last updated: May 31, 2017
• Start date: December 21, 2012
• Est. completion date: May 14, 2017

Study information

• Verified date: May 2017
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: May 14, 2017
• Est. primary completion date: May 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Exoseal closure device
Closure device for femoral artery access closure
• Angioseal closure device
Closure device for femoral artery access closure

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Cordis Corporation, St. Jude Medical

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)	This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.	30 days
Secondary	Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis	Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event	participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	Device failure	Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.	30 minutes
Secondary	Vasovagal reaction until 5 minutes after end of closure procedure		30 minuts
Secondary	Need for new onset of manual compression		30 days
Secondary	Pain and discomfort related to the closure procedure	Assessed on a numerical rating scale (NRS) from 0 (no pain or discomfort) to 10 (worst possible pain or discomfort) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed	Closure procedure and 30 days
Secondary	Time to mobilization	From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately	participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	In-hospital large groin haematoma	Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge	participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	Bleedings according to the BARC definitions	Access site related and non-access site related	30 days
Secondary	Major bleeding and/or bleeding necessitating blood transfusion		6 months
Secondary	Pseudoaneurysm with indication for treatment		30 days and 6 months
Secondary	Arteriovenous fistula		30 days and 6 months
Secondary	Groin surgery and/or possible related vascular surgery		30 days and 6 months
Secondary	Infection needing antibiotics		30 days and 6 months
Secondary	Need for medical evaluation of possible closure procedure related symptom(s)		30 days