Percutaneous Closure of Artery Access Sites Clinical Trial
Official title:
InSeal VCD Large Bore Vascular Closure Device Clinical Study
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01896401 -
InSeal Vascular Closure Device Clinical Study Protocol
|
N/A |