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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02237430
• Date of registration: 04/09/2014
• Prospective Registration: No
• Primary sponsor: Aarhus University Hospital Skejby
• Public 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 CLOSE-UP III
• Scientific 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
• Date of first enrolment: June 16, 2014
• Target sample size: 869
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02237430
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Evald H Christiansen, MD
• Affiliation: Aarhus University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Disease

Intervention(s)

Device: MynxGrip

Other: Manual compression

Primary Outcome(s)

Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE) [Time Frame: 30 days]

Secondary Outcome(s)

Arteriovenous fistula [Time Frame: 30 days and 6 months]

Bleedings according to the Bleeding Academic Research Consortium (BARC) definitions [Time Frame: 1 hour and 30 days]

Pain and discomfort related to the closure procedure [Time Frame: Closure procedure and 30 days]

In-hospital large groin haematoma [Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days]

Need for new onset of manual compression [Time Frame: 30 days]

Time (min) to haemostasis [Time Frame: 30 days]

Device failure [Time Frame: 30 minutes]

Groin surgery and/or possible related vascular surgery [Time Frame: 30 days and 6 months]

Infection needing antibiotics [Time Frame: 30 days and 6 months]

Need for medical evaluation of possible closure procedure related symptom(s) [Time Frame: 30 days]

Time to mobilization [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 days]

Pseudoaneurysm with indication for treatment [Time Frame: 30 days and 6 months]

Major bleeding and/or bleeding necessitation blood transfusion [Time Frame: 30 days and 6 months]

Vasovagal reaction until 5 minutes after end of closure procedure [Time Frame: 30 minutes]

Secondary ID(s)

CLOSE-UP III

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vingmed Danmark A/S