An interventional study of Exoseal closure device and Angioseal closure device in Coronary Disease, sponsored by Aarhus University Hospital Skejby. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
Is the ExoSeal VSD non-inferior to Angio-Seal vascular closure device (VSD) in the incidence of adverse access site related events at 30 days.
Prospective, randomized (1:1) controlled, single blind, single center study in 2000 percutaneous coronary intervention (PCI) patients comparing the ExoSeal VCD (test device) to the AngioSeal VCD (standard comparator). In-hospital and 30 days safety and efficacy endpoints and 6 months safety endpoints will be reported.
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's enrollment of 818 is above the median of 124 across 1,583 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Closure device for femoral artery access closure
Device: Exoseal closure device
Closure device for femoral artery access closure
Device: Angioseal closure device
Closure device for femoral artery access closure
Closure device for femoral artery access closure
Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE)
This includes: major bleeding and/or bleeding necessitating blood transfusion, pseudoaneurysm with indication for treatment, arteriovenous fistula, groin surgery and/or possible related vascular surgery, infection needing antibiotics.
Time frame: 30 days
Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis
Insignificant bleeding seen on the bandage or small continuous oozing is considered haemostasis. Continuous oozing will be counted as a Bleeding Academic Research Consortium (BARC) type 1 bleeding event
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Device failure
Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported.
Time frame: 30 minutes
Vasovagal reaction until 5 minutes after end of closure procedure
Time frame: 30 minuts
Need for new onset of manual compression
Time frame: 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) Scripted language will be used when discussing pain scores with the patient. Pain and discomfort score will be assessed just before and immediately after the closure procedure and reported. The delta-value will be reported and compared. The patient will be given predefined standardized instructions on how to rate and that only pain and discomfort related to the closure procedure should be assessed
Time frame: Closure procedure and 30 days
Time to mobilization
From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
In-hospital large groin haematoma
Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 days
Bleedings according to the BARC definitions
Access site related and non-access site related
Time frame: 30 days
Major bleeding and/or bleeding necessitating blood transfusion
Time frame: 6 months
Pseudoaneurysm with indication for treatment
Time frame: 30 days and 6 months
Arteriovenous fistula
Time frame: 30 days and 6 months
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
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital Skejby