InSeal Vascular Closure Device Clinical Study Protocol

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 efficaient in achieving hemostasis in the study population.

Official Title
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InSeal Vascular Closure Device Clinical Study Protocol

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. 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 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's Vascular Closure Device<br>Use of the experimental VCD to close the access site of the artery | Device: InSeal's Vascular Closure Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Combined rate of closure-device related major adverse events in first month |  | 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