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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: MynxGrip
* Other: Manual compression


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manuel compression<br>Conventional manual compression | Other: Manual compression<br>* Conventional manual compression<br>|
| Experimental: MynxGrip closure device<br>Closure device for femoral artery access closure | Device: MynxGrip<br>* Closure device for femoral artery access closure<br>* Other names: Closure device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (min) to haemostasis | From inserting the device (MynxGrip) until haemostasis and from beginning of manual compression to immediately haemostasis | 30 days | 
| Device failure |  | 30 minutes | 
| Vasovagal reaction until 5 minutes after end of closure procedure |  | 30 minutes | 
| 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). | Closure procedure and 30 days | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary angiography (CAG)