The InSeal vascular closure device (VCD) is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures. The study hypothesis is that the VCD is safe and efficient in achieving hemostasis in the study population.
The increasing variety of arterial devices having a large crossing profile requiring the use of a large bore sheath is mandating focus on large bore closure. Such procedures include endovascular abdominal repair (EVAR), thoracic (TEVAR) aortic repairs and transcatheter aortic valve implantation (TAVI) typically involve sheaths and delivery catheters with 14-25Fr profiles. Today, the typical closing technique (labeled in Europe) for such large sheath size is a one where sutures are deployed prior to the insertion of the large sheath with the sutures tied at the end of the procedure. This technique is cumbersome, hard to learn, complex to use and has relative high complications and failure rate. The InSeal VCD device model 13-517, is easy to use, fast, affords immediate reliable hemostasis, and supports a wide range of sheath punctures size and artery's dia. 6-10 mm, while leaving a minimal amount material behind and will not limit re-access. While each of these features may be found in one commercial device or another, to date there is no single device that meets all the market requirements.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Intravascular closure device
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Hemostasis within 15 minutes
Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 seconds. Measured by operator using standard time measuring device (e.g., stopwatch)
Time frame: 15 minutes
Combined rate of closure-device related major adverse events
Combined rate of closure-device related major adverse events in first month as assessed by CTCAE v4.0
Time frame: 1 month
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