CaveoVasc System - a New Femoral Vascular Access and Closure Device

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CaveoVasc	CaveoVasc	-

Primary Outcome Measures

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

Secondary Outcome Measures