CaveoVasc System - a New Femoral Vascular Access and Closure Device

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

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.

Study Overview

• Status: Terminated
• Conditions: Catheterization Via a Femoral Sheath ≤ 6Fr
• Intervention / Treatment: Device: CaveoVasc

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CaveoVasc	Device: CaveoVasc

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CaveoMed GmbH
• Collaborators: MedPass International

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2016
• Primary Completion (Actual): October 10, 2016
• Study Completion (Actual): November 10, 2016

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Vascular Access Devices; Vascular Closure Devices; Catheterization Closure Devices
• Other Study ID Numbers: CaveoMed-2015-06