CaveoVasc System - a New Femoral Vascular Access and Closure Device

Catheterization Via a Femoral Sheath = 6Fr Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02694549
• Other study ID #: CaveoMed-2015-06
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2016
• Est. completion date: November 10, 2016

Study information

• Verified date: August 2018
• Source: CaveoMed GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 10, 2016
• Est. primary completion date: October 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Catheterization Via a Femoral Sheath = 6Fr

Intervention

Device:
• CaveoVasc

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CaveoMed GmbH	MedPass International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).		30 days
Primary	Primary Performance Endpoint	Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site	30 days
Secondary	Secondary Safety Endpoint	Safety: Incidence of all adverse events at 30 days	30 days