Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vingmed Danmark A/S | INDIV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?
Access site complication after coronary angiography is still a challenge in everyday practice. The FemoSeal® closure device has proven very safe as shown in the swedish SCAAR registry. This study is aimed to investigate, in a randomized design, if the FemoSeal® has an advantage in safety and efficacy over manual compression.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FemoSeal® | Experimental | Closure device for femoral artery access closure |
|
| Manual compression | Active Comparator | Conventional manual compression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemoSeal® | Device | Closure device for femoral artery access closure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. | 20 minutes, 1 hour and at discharge, pooled |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements. | 14 days | |
| Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics . |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Niels R. Holm, MD | Aarhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital Skejby | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24603054 | Derived | Holm NR, Sindberg B, Schou M, Maeng M, Kaltoft A, Bottcher M, Krusell LR, Hjort J, Thuesen L, Terkelsen CJ, Christiansen EH, Botker HE, Kristensen SD, Lassen JF; CLOSE-UP study group. Randomised comparison of manual compression and FemoSeal vascular closure device for closure after femoral artery access coronary angiography: the CLOSure dEvices Used in everyday Practice (CLOSE-UP) study. EuroIntervention. 2014 Jun;10(2):183-90. doi: 10.4244/EIJV10I2A31. | |
| 23532433 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Manual compression |
| Other |
Conventional manual compression |
|
| 14 days |
| Time to hemostasis, from sheath removal to hemostasis is achieved | 14 days |
| Time from end of closure procedure to ambulation. 1h bedrest recommended. | 14 days |
| Device deployment failure | 20 minutes |
| Time to cessation of continuous minor oozing measured from the end of the closure procedure | 14 days |
| Need for repeated manual compression after end of the closure procedure | 14 days |
| Pain and discomfort measured on a numerical pain rating scale (0-10) | 20 min |
| Vasovagal reaction (clinical signs AND Systolic BP drop of more than 30 mmHg AND/OR pulse drop more than 30 b/min. AND reversible immediately after treatment by atropin, fluids) | 20 minutes |
| The patient seeking medical assistance for all-cause closure site related symptoms after discharge. | 14 days |
| Pain and discomfort measured on a numerical pain rating scale (0-10) | 1 hour |
| Pain and discomfort measured on a numerical pain rating scale (0-10) | Discharge |
| Pain and discomfort measured on a numerical pain rating scale (0-10) | 14 days |
| Derived |
| Sindberg B, Schou M, Hansen L, Christiansen KJ, Jorgensen KS, Soltoft M, Holm NR, Maeng M, Kristensen SD, Lassen JF. Pain and discomfort in closure of femoral access coronary angiography. The CLOSuredEvices Used in everyday Practice (CLOSE-UP) pain sub study. Eur J Cardiovasc Nurs. 2014 Jun;13(3):221-6. doi: 10.1177/1474515113482809. Epub 2013 Mar 25. |