Coronary Disease
Conditions
Keywords
PCI
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExoseal closure device
Closure device for femoral artery access closure
DEVICEAngioseal closure device
Closure device for femoral artery access closure
Sponsors
Cordis US Corp.
Abbott Medical Devices
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Should be able to provide valid informed signed consent * PCI procedure including treatment by balloon and/or stent * PCI indicated by silent ischemia, stable angina pectoris, non-ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI)
Exclusion criteria
* Only coronary angiography * Multiple punctures * Active infection * Groin haematoma before the closure procedure * Sheath size \> 7 French * Known pseudoaneurysm or arteriovenous (AV)-fistula in the ipsilateral groin * Prior arterial surgery in abdomen and/or lower extremities * Cardiogenic shock * Life expectancy less than one year * The patient is a female of childbearing potential with possible pregnancy or a positive pregnancy test within 7 days before the index procedure or is lactating * Simultaneous or planned subsequent femoral vein access * Allergy to any of the components in the closure material left in the groin * Puncture on same site \< 30 days * Peripheral artery disease patients can be included at operator´s discretion except if heavy calcification is present at the access site which at the operator's discretion precludes insertion of the VCD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence at 30 days of the composite endpoint of access site related major adverse vascular events (MAVE) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device failure | 30 minutes | Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported. |
| Vasovagal reaction until 5 minutes after end of closure procedure | 30 minuts | — |
| Need for new onset of manual compression | 30 days | — |
| Pain and discomfort related to the closure procedure | Closure procedure and 30 days | 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 to mobilization | participants will be followed for the duration of hospital stay, an expected average of 2 days | From start of closure procedure to patient is mobilized. Patients treated for ST-elevation myocardial infarction are assessed separately |
| In-hospital large groin haematoma | participants will be followed for the duration of hospital stay, an expected average of 2 days | Larger than 5x5 cm measured by ruler in the catheterization laboratory and at discharge |
| Time to haemostasis from removing the sheath (AngioSeal) or inserting the device (ExoSeal) until haemostasis | participants will be followed for the duration of hospital stay, an expected average of 2 days | 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 |
| Major bleeding and/or bleeding necessitating blood transfusion | 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 | — |
| Bleedings according to the BARC definitions | 30 days | Access site related and non-access site related |
Countries
Denmark
Outcome results
None listed