Clinical trial NCT01001663: Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography
Official title: Comparison of the FemoSeal® Arterial Closure Device to Manual Compression After Coronary Angiography: the CLOSE-UP I Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Angiography Via Femoral Artery Access
Keywords: CAG
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Vingmed Danmark A/S
First posted: 2009-10-26
Enrollment: 1005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is the FemoSeal® closure device safer and more comfortable than manual compression for femoral artery access closure after coronary angiography?

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient must be at least 18 years old
* Patients undergoing femoral access coronary angiography
* Patient must be competent for providing informed, written consent
* Only 6F sheath

Exclusion Criteria:

* Percutaneous coronary intervention
* Intra coronary measurements (FFR, IVUS, OCT, NIR)
* Groin hematoma before closure
* Pseudoaneurysm or AV fistula
* Significant stenosis of ilial or femoral artery
* Prior peripheral artery surgery
* INR \> 3,0
* Platelet count \< 120 million per millilitre blood
* Coagulopathy (bleeding disorder)
* Thrombolysis in the last 24h
* Planned heparin infusion after the procedure
* Pregnancy
* Uncontrolled hypertension \> 200 mmHg / 110 mmHg
* Femoral access device closure in the last 30 days

Primary outcomes:
measure: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm.
timeFrame: 20 minutes, 1 hour and at discharge, pooled
Secondary outcomes:
measure: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. Patient self-measurements.
timeFrame: 14 days
measure: Composite of: major vascular complications necessitating surgical repair, A-V fistulation, pseudoaneurysm needing treatment, major bleeding needing transfusion and infection needing antibiotics .
timeFrame: 14 days
measure: Time to hemostasis, from sheath removal to hemostasis is achieved
timeFrame: 14 days
measure: Time from end of closure procedure to ambulation. 1h bedrest recommended.
timeFrame: 14 days
measure: Device deployment failure
timeFrame: 20 minutes
measure: Time to cessation of continuous minor oozing measured from the end of the closure procedure
timeFrame: 14 days
measure: Need for repeated manual compression after end of the closure procedure
timeFrame: 14 days
measure: Pain and discomfort measured on a numerical pain rating scale (0-10)
timeFrame: 20 min
measure: 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)
timeFrame: 20 minutes
measure: The patient seeking medical assistance for all-cause closure site related symptoms after discharge.
timeFrame: 14 days
measure: Pain and discomfort measured on a numerical pain rating scale (0-10)
timeFrame: 1 hour
measure: Pain and discomfort measured on a numerical pain rating scale (0-10)
timeFrame: Discharge
measure: Pain and discomfort measured on a numerical pain rating scale (0-10)
timeFrame: 14 days
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital Skejby
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Niels R. Holm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.