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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: Exoseal closure device; Device: Angioseal closure device

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.

• Study Type: Interventional
• Enrollment (Actual): 818
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exoseal closure device; Closure device for femoral artery access closure	Device: Exoseal closure device; Closure device for femoral artery access closure
Active Comparator: Angio-Seal closure device; Closure device for femoral artery access closure	Device: Angioseal closure device; Closure device for femoral artery access closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Vasovagal reaction until 5 minutes after end of closure procedure		30 minuts
Need for new onset of manual compression		30 days
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
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
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
Bleedings according to the BARC definitions	Access site related and non-access site related	30 days
Major bleeding and/or bleeding necessitating blood transfusion		6 months
Pseudoaneurysm with indication for treatment		30 days and 6 months
Arteriovenous fistula		30 days and 6 months
Groin surgery and/or possible related vascular surgery		30 days and 6 months
Infection needing antibiotics		30 days and 6 months
Need for medical evaluation of possible closure procedure related symptom(s)		30 days

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Abbott Medical Devices; Cordis Corporation
• Investigators: Principal Investigator: Evald H Christiansen, MD, PhD, Arhus University Hospital Skejby

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2012
• Primary Completion (Actual): May 14, 2016
• Study Completion (Actual): May 14, 2017

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 1, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: PCI
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: 1-10-72-68-12