Catheterization Via a Femoral Sheath ≤ 6FrNCT02694549
CaveoVasc System - a New Femoral Vascular Access and Closure Device
A study testing CaveoVasc in people with Catheterization Via a Femoral Sheath ≤ 6Fr, run by CaveoMed GmbH.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheterization Via a Femoral Sheath ≤ 6Fr
- What is being tested?
- CaveoVasc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 9 Aug 2016to 10 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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
About this study
Official title: 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.
- Being tested
- CaveoVasc
- Keywords
- Vascular Closure Devices, Catheterization Closure Devices, Vascular Access Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaveoVascDevice
| Study group | Role | What they receive |
|---|---|---|
| CaveoVasc | Experimental | Not described Receives: Device: CaveoVasc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).
Measured: 30 days
Primary Performance Endpoint
Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site
Measured: 30 days
Secondary outcomes (1)
Secondary Safety Endpoint
Safety: Incidence of all adverse events at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study start9 Aug 2016
- Primary completion10 Oct 2016
- Study completion10 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Catheterization Via a Femoral Sheath ≤ 6FrStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CaveoMed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694549
- Sponsor's protocol ID
- CaveoMed-2015-06
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2016
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm Study to Assess the Performance and Safety of CaveoVasc System for Femoral Vascular Access and Closure Device
- ClinicalTrials.gov ID
- NCT02694549
- Acronym / sponsor ID
- CaveoMed-2015-06
- Keywords
- Vascular Closure Devices, Catheterization Closure Devices, Vascular Access Devices
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CaveoMed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 10 Oct 2016 (actual)
- Study completion
- 10 Nov 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Posted 28 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CaveoVasc | Experimental | Device: CaveoVasc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaveoVasc | Device | CaveoVasc |
Primary outcome
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).
Time frame: 30 days
Primary Performance Endpoint
Time frame: 30 days
Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site
1 secondary outcome
Secondary Safety Endpoint
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CaveoVasc in people with Catheterization Via a Femoral Sheath ≤ 6Fr, run by CaveoMed GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE). (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.