Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial

Not Applicable

Completed

• Conditions: Coronary Disease
• Interventions: Device: MynxGrip; Other: Manual compression

• Registration Number: NCT02237430
• Lead Sponsor: Aarhus University Hospital Skejby

Brief Summary

Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.

Detailed Description

Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.

Study Timeline

• Study Start: 2014-06-16
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Primary Completion: 2017-05-16
• Study Completion: 2018-12-16
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-07
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 869

Inclusion Criteria

• >18 year
• Should be able to provide valid informed signed consent
• CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)

Exclusion Criteria

• Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
• ST-Elevations Myocardial Infarction (STEMI)
• Multiple punctures
• Active infection
• Groin haematoma before the closure procedure
• Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin
• Cardiogenic shock
• Prior peripheral arterial surgery in abdomen or lower extremities
• Sheat size >7 F
• Life expectancy less than one year
• Possible pregnancy or positive pregnancy test or breastfeeding women
• Simultaneous or planned subsequent femoral vein access
• Allergy to any of the components in the closure material left in the groin
• Puncture or closure with closure device at same site < 30 days
• Puncture or closure with manuel compression at same site < 5 days
• Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MynxGrip closure device	MynxGrip	Closure device for femoral artery access closure
Manuel compression	Manual compression	Conventional manual compression

Primary Outcome Measures

Name	Time	Method
Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE)	30 days	This includes: Major bleeding and/or blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery of leg, definitely or possible can be related to the closure procedure, infection needing antibiotics.

Secondary Outcome Measures

Name	Time	Method
Need for medical evaluation of possible closure procedure related symptom(s)	30 days
Need for new onset of manual compression	30 days
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).
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 mobilised.
Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions	1 hour and 30 days
Major bleeding and/or bleeding necessitation blood transfusion	30 days and 6 months
Pseudoaneurysm with indication for treatment	30 days and 6 months
Arteriovenous fistula	30 days and 6 months
Vasovagal reaction until 5 minutes after end of closure procedure	30 minutes
Time (min) to haemostasis	30 days	From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis
In-hospital large groin haematoma	Participants will be followed for the duration of hospital stay, an expected average of 2 days	Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge
Groin surgery and/or possible related vascular surgery	30 days and 6 months
Infection needing antibiotics	30 days and 6 months
Device failure	30 minutes

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Denmark