CaveoVasc System - a New Femoral Vascular Access and Closure Device

NCT02694549 | Terminated Results

• 1 other identifier: CaveoMed-2015-06
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

Vascular Closure Devices; Catheterization Closure Devices; Vascular Access Devices

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Safety Endpoint

  30 days

Study Arms (1)

CaveoVasc

EXPERIMENTAL

Device: CaveoVasc

Interventions

CaveoVasc DEVICE

CaveoVasc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CaveoMed GmbH: lead
• MedPass International: collaborator

Results Point of Contact

• Title: Albertus M. Scheule, MD, PhD, MBA
• Organization: CaveoMed GmbH

albertus.scheule@caveomed.com

+49(0)7071-53982-10

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: February 29, 2016
• Study Start: August 9, 2016
• Primary Completion: October 10, 2016
• Study Completion: November 10, 2016
• Last Updated: August 28, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-08