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This original design is no longer consistent with current clinical practice.
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FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micropuncture | Active Comparator |
| |
| Standard | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micropuncture needle set | Device | Groin access for vascular intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major Peripheral Vascular Events | Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral | 7 - 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco, Fresno, School of Medicine | Fresno | California | 93701 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Micropuncture | Gauge-21 Micropuncture® needle |
| FG001 | Routine Access | Standard gauge-18 large-bore needle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micropuncture | Gauge-21 Micropuncture® needle |
| BG001 | Routine Access | Standard gauge-18 large-bore needle |
| 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 Peripheral Vascular Events | Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral | Posted | Number | participants | 7 - 14 days |
|
Up to 4 weeks
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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 | Micropuncture | Gauge-21 Micropuncture® needle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis > 15 cm | Injury, poisoning and procedural complications | Systematic Assessment | Ecchymosis > 15 cm at the vascular access site seen during follow-up |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder, PhD, Director of Clinical Affairs | Cook Research Incorporated | 765-463-7537 | Scott.Snyder@CookMedical.com |
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| Standard gauge-18 needle set |
| Device |
Groin access for vascular intervention |
|
| St. Vincent Hospital |
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Micropuncture |
Gauge-21 Micropuncture® needle |
| OG001 | Routine Access | Standard gauge-18 large-bore needle |
|
|
| 0 |
| 67 |
| 12 |
| 67 |
| EG001 | Routine Access | Standard gauge-18 large-bore needle | 1 | 76 | 15 | 76 |
|
| Groin bleeding | Injury, poisoning and procedural complications | Systematic Assessment | Groin bleeding including oozing or spurting after standard compression time necessitating further compression |
|
| Groin hematoma | Injury, poisoning and procedural complications | Systematic Assessment | Groin hematoma ≥ 5 cm noted at any time during or after the procedure |
|
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