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The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X-Seal 6F Vascular Closure Device | Experimental | The X-Seal 6F Vascular Closure device will be used to achieve hemostasis in both diagnostic and interventional procedures using up to a 6F procedure sheath. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-Seal 6F Vascular Closure Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Complications | The rate of major complications within approximately 30 days following the procedure. | 30 days |
| Time-to-Hemostasis | Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding. | Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Ambulation | The time from end of the procedure until the patient ambulates for the first time. | Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients. |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lubeck Hospital | Lübeck | Germany | ||||
| University of Rostock Hosptial |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic | Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure. |
| FG001 | Interventional | Patients treated with X-Seal device that underwent an interventional catheter procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic | Patients treated with X-Seal device that were undergoing a diagnostic catheter procedure. |
| BG001 | Interventional | Patients treated with X-Seal device that underwent an interventional catheter procedure. |
| 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 | Major Complications | The rate of major complications within approximately 30 days following the procedure. | Posted | Count of Participants | Participants | 30 days |
|
|
30 days post-procedure
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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 | Diagnostic | Patients treated with X-Seal device that underwent a diagnostic catheter procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New catheterization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Nardone | Essential Medical | 6105571009 | sam@essmedclosure.com |
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The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related. |
| 30 days |
| Rostock |
| Germany |
| Guidewire Failure |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ankle-Brachial Index (ABI) | Mean | Standard Deviation | Ratio |
|
| Participants |
|
|
| Primary | Time-to-Hemostasis | Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding. | Posted | Mean | Standard Deviation | Minutes | Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours. |
|
|
|
| Secondary | Time-to-Ambulation | The time from end of the procedure until the patient ambulates for the first time. | Subjects for whom ambulation data are available | Posted | Mean | Standard Deviation | hours | Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients. |
|
|
|
| Secondary | Adverse Events | The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 26 |
| 1 |
| 26 |
| 1 |
| 26 |
| EG001 | Interventional | Patients treated with X-Seal device that underwent an interventional catheter procedure. | 0 | 21 | 4 | 21 | 6 | 21 |
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Pancreatitis | Endocrine disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Pressure at access site | Vascular disorders | Systematic Assessment |
|
| Guidewire tip detachment | Product Issues | Systematic Assessment |
|
| Bleeding from contralateral access site | Vascular disorders | Systematic Assessment |
|
| Pain at access site | Vascular disorders | Systematic Assessment |
|
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