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

Coronary Disease Clinical Trial

— CLOSE-UP III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237430
• Other study ID #: CLOSE-UP III
• Status: Completed
• Phase: N/A
• Start date: June 16, 2014
• Est. completion date: December 16, 2018

Study information

• Verified date: May 2019
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 869
• Est. completion date: December 16, 2018
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• MynxGrip
Closure device for femoral artery access closure

Other:
• Manual compression
Conventional manual compression

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Vingmed Danmark A/S

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 serious access site related major adverse vascular events (MAVE)	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.	30 days
Secondary	Time (min) to haemostasis	From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis	30 days
Secondary	Device failure		30 minutes
Secondary	Vasovagal reaction until 5 minutes after end of closure procedure		30 minutes
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).	Closure procedure and 30 days
Secondary	Time to mobilization	From start of closure procedure to patient is mobilised.	participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	In-hospital large groin haematoma	Larger than 5 x 5 cm measured by ruler in the catheterisation laboratory or at discharge	Participants will be followed for the duration of hospital stay, an expected average of 2 days
Secondary	Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions		1 hour and 30 days
Secondary	Major bleeding and/or bleeding necessitation blood transfusion		30 days and 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