Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02694549
NCT02694549TerminatedNot Applicable

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

CaveoMed GmbH0 sites12 target enrollmentStarted: August 9, 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
12
Primary Endpoint
Primary Performance Endpoint
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

CaveoVasc

Experimental

Intervention: CaveoVasc (Device)

Outcomes

Primary Outcomes

Primary Performance Endpoint

Time Frame: 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).

Time Frame: 30 days

Secondary Outcomes

  • Secondary Safety Endpoint(30 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Unknown
Not Applicable
CaveoVasc Thrombolysis Protection System, Access Protection StudyThrombolysis
NCT03166059CaveoMed GmbH20
Recruiting
Not Applicable
The Safety and Effectiveness of CVA-FLOW Software Device for Acute Ischemic StrokeStroke, AcuteStroke, IschemicStroke HemorrhagicStroke, CardiovascularStroke
NCT05745051Cvaid Medical100
Unknown
Phase 2
The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic CancerChemotherapy EffectPancreatic Cancer
NCT04581876Fudan University120
Unknown
Phase 1
VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility StudyIschemic Heart DiseaseLeft Ventricular DysfunctionMitral Valve RegurgitationMitral IncompetenceMitral InsufficiencyHeart Failure
NCT00512005Myocor30
Unknown
Not Applicable
The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance CriteriaCoronary Artery Disease
NCT04617899CardioNavi MedTech (Wuhan) Co., Ltd.120