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| Name | Class |
|---|---|
| Vingmed Danmark A/S | INDIV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manuel compression | Active Comparator | Conventional manual compression |
|
| MynxGrip closure device | Experimental | Closure device for femoral artery access closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MynxGrip | Device | Closure device for femoral artery access closure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evald H Christiansen, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35196986 | Derived | Jakobsen L, Holm NR, Maeng M, Thim T, Kristensen SD, Mogensen LH, Christiansen EH. Comparison of MynxGrip vascular closure device and manual compression for closure after femoral access angiography: a randomized controlled trial: the closure devices used in every day practice study, CLOSE-UP III trial. BMC Cardiovasc Disord. 2022 Feb 23;22(1):68. doi: 10.1186/s12872-022-02512-0. |
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| Manual compression | Other | Conventional manual compression |
|
| 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 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D065506 | Vascular Closure Devices |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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