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

Not Applicable

Completed

• Conditions: Coronary Disease
• Interventions: Device: Exoseal closure device; Device: Angioseal closure device

• Registration Number: NCT02234830
• Lead Sponsor: Aarhus University Hospital Skejby

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.

Study Timeline

• Study Start: 2012-12-21
• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Primary Completion: 2016-05-14
• Status Verified: 2017-05
• Study Completion: 2017-05-14
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 818

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exoseal closure device	Exoseal closure device	Closure device for femoral artery access closure
Angio-Seal closure device	Angioseal closure device	Closure device for femoral artery access closure

Primary Outcome Measures

Name	Time	Method
Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Arteriovenous fistula	30 days and 6 months
Device failure	30 minutes	Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.
Groin surgery and/or possible related vascular surgery	30 days and 6 months
Vasovagal reaction until 5 minutes after end of closure procedure	30 minuts
Pain and discomfort related to the closure procedure	Closure procedure and 30 days	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
Pseudoaneurysm with indication for treatment	30 days and 6 months
Bleedings according to the BARC definitions	30 days	Access site related and non-access site related
Major bleeding and/or bleeding necessitating blood transfusion	6 months
Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis	participants will be followed for the duration of hospital stay, an expected average of 2 days	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
Need for new onset of manual compression	30 days
In-hospital large groin haematoma	participants will be followed for the duration of hospital stay, an expected average of 2 days	Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge
Infection needing antibiotics	30 days and 6 months
Time to mobilization	participants will be followed for the duration of hospital stay, an expected average of 2 days	From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately
Need for medical evaluation of possible closure procedure related symptom(s)	30 days

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark