CaveoVasc System - a New Femoral Vascular Access and Closure Device

Study Overview
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Brief Summary
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The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.

Official Title
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Prospective, Single Arm Study to Assess the Performance and Safety of CaveoVasc System for Femoral Vascular Access and Closure Device

Conditions
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Catheterization Via a Femoral Sheath ≤ 6Fr

Intervention / Treatment
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* Device: CaveoVasc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Patients eligible for a non-emergent diagnostic or interventional catheterization via a femoral sheath of less or equal 6Fr In the investigator's opinion, the patient is suitable for the CaveoVasc® System , conventional hemostasis techniques and participation in an investigational trial. Understand and sign the study specific written informed consent form. Exclusion Criteria: Patients with significant anemia (hemoglobin <10g/DL, Hct<30). Patients with a baseline INR > 1.5 Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100,000 mm3), patients with chronic use of vitamin K antagonists, direct thrombin inhibitors or oral factor Xa antagonists Severe concomitant disease with life expectancy below 12 months Uncontrolled systemic hypertension Patients who are immunocompromised. Patients who need a puncture needle longer than 8 cm due to morbidity obesity Active systemic or cutaneous infection or inflammation Prior arterial surgery in abdomen and/or lower extremities Cardiogenic shock Patients who are known to be pregnant or lactating. Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula. Prior femoral vascular surgery or vascular graft in region of access site. Documented chronic peripheral arterial insufficiency preventing the use of the femoral technique Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period. Patients with known allergy to components of the device. Patients who cannot adhere to or complete the investigational protocol for any reason

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CaveoVasc<br> | Device: CaveoVasc<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE). |  | 30 days | 
| Primary Performance Endpoint | Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint | Safety: Incidence of all adverse events at 30 days | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Closure Devices, Catheterization Closure Devices, Vascular Access Devices