CaveoVasc System - a New Femoral Vascular Access and Closure Device

NCT ID: NCT02694549

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-09
• Study Completion Date: 2016-11-10

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.

Conditions

Catheterization Via a Femoral Sheath ≤ 6Fr

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER

Study Groups

CaveoVasc

Group Type: EXPERIMENTAL

CaveoVasc

Intervention Type: DEVICE

Interventions

CaveoVasc

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedPass International

INDUSTRY

Sponsor Role: collaborator

CaveoMed GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CaveoMed-2015-06

Identifier Type: -

Identifier Source: org_study_id