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| Name | Class |
|---|---|
| MedPass International | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CaveoVasc | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CaveoVasc | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoint | Safety: Incidence of all adverse events at 30 days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | CaveoVasc | Patients treated with CaveoVasc System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CaveoVasc | Patients treated with CaveoVasc System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE). | Posted | Count of Participants | Participants | 30 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CaveoVasc | Patients treated with CaveoVasc System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High Blood Pressure | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Vascular disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Albertus M. Scheule, MD, PhD, MBA | CaveoMed GmbH | +49(0)7071-53982-10 | albertus.scheule@caveomed.com |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Primary Performance Endpoint | Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Secondary Safety Endpoint | Safety: Incidence of all adverse events at 30 days | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 10 |
| 10 |
| 7 |
| 10 |
| Device deficiency : Access issue | Vascular disorders |
|
| Device Deficiency : closure issue | Vascular disorders |
|
| Hematoma | Vascular disorders |
|
| Angina Pectoris | Cardiac disorders |
|
| Bleeding after procedure no compression necessary | Vascular disorders |
|
| Bleeding at the access site | Vascular disorders |
|
| Bleeding puncture site | Vascular disorders |
|
| Bleeding right groin up to 10 days after intervention | Vascular disorders |
|
| Diffuse hematoma | Vascular disorders |
|
| Hematoma and Induration right groin | Vascular disorders |
|
| Hematoma 0.9x2.3cm left groin | Vascular disorders |
|
| Hematoma right groin | Vascular disorders |
|
| High blood pressure during procedure 199/56mmHg | Cardiac disorders |
|
| not adequate placement of the device due to anatomical reason, iliac artery kinking | Vascular disorders |
|
| short confusion and loss in memory due to sedation | Surgical and medical procedures |
|
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