Catheterization Via a Femoral Sheath ≤ 6Fr
Conditions
Keywords
Vascular Closure Devices, Catheterization Closure Devices, Vascular Access Devices
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.
Interventions
DEVICECaveoVasc
Sponsors
MedPass International
CaveoMed GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days | Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint | 30 days | Safety: Incidence of all adverse events at 30 days |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CaveoVasc Patients treated with CaveoVasc System | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen failures | 2 |
Baseline characteristics
| Characteristic | CaveoVasc |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment Germany | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 10 / 10 |
Outcome results
Primary
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaveoVasc | Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE). | 2 Participants |
Primary
Primary Performance Endpoint
Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaveoVasc | Primary Performance Endpoint | 3 Participants |
Secondary
Secondary Safety Endpoint
Safety: Incidence of all adverse events at 30 days
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CaveoVasc | Secondary Safety Endpoint | 2 Participants |