InSeal VCD Large Bore Vascular Closure Device Safety and Effectiveness Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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InSeal VCD Large Bore Vascular Closure Device Clinical Study

Conditions
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Percutaneous Closure of Artery Access Sites

Intervention / Treatment
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* Device: InSeal's Vascular Closure Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath. Femoral, axillary or subclavian artery diameter at sheath insertion site is between 5.5-10mm Subject age is at least 18 years Patient has signed most recent approved version of the Informed Consent Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution. Exclusion Criteria: Women Of Child Bearing Potential (WOCBP) Legally non-competent patients Patient participating in another clinical study at the time of the InSeal VCD study Sheath insertion point is less than 12mm proximal to a bifurcation having a diameter greater than 2.5mm Side branch of greater than 2.5mm in diameter less than 4cm proximal to the puncture site. Known severe allergy to metal and membrane material Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment Prior vascular surgery or vascular graft in region of access site Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InSeal VCD<br>InSeal's Vascular Closure Device Use of the experimental VCD to close the access site of the artery | Device: InSeal's Vascular Closure Device<br>* Intravascular closure device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large bore endovascular catheterization procedures, Vascular Closure Device