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| Name | Class |
|---|---|
| Cordis US Corp. | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exoseal closure device | Experimental | Closure device for femoral artery access closure |
|
| Angio-Seal closure device | Active Comparator | Closure device for femoral artery access closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoseal closure device | Device | Closure device for femoral artery access closure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | participants will be followed for the duration of hospital stay, an expected average of 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evald H Christiansen, MD, PhD | Arhus University Hospital Skejby | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | 8200 | Denmark | |||
| Odense University Hospital |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Angioseal closure device |
| Device |
Closure device for femoral artery access closure |
|
| Device failure | Combined endpoint of any mechanic failure, deployment failure and/or immediate profuse bleeding needing prolonged manual compression. Individual endpoints will be reported. | 30 minutes |
| 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 | 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 | 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 | 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 | 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 | 30 days |
| 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 |
| Odense |
| 5000 |
| Denmark |