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The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE VIABHAN Endoprothesis | Experimental | Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface | Device | Endovascular treatment of the study lesion with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency at 12 Months | Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days | If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. |
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Inclusion Criteria:>
Exclusion Criteria:>
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| Name | Affiliation | Role |
|---|---|---|
| Richard Saxon, MD | North County Radiology Medial Group Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-City Medical Center | Oceanside | California | 92056 | United States | ||
| Mercy Hospital and Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gore Viabahn Endoprosthesis | All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 30 days |
| Primary Assisted Patency | Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency. | 12 months |
| Secondary Patency | Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency. | 12 months |
| Device-related Major Adverse Events at 12 Months | If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. | 12 months |
| Chicago |
| Illinois |
| 60616 |
| United States |
| Columbia Surgical Associates | Columbia | Missouri | 65201 | United States |
| Baylor University Medical Center | Dallas | Texas | 75226 | United States |
| St. Luke's Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Subjects | The total number of enrolled subjects. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Primary Patency at 12 Months | Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area). | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
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| Secondary | Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days | If the functioning or characteristics of the device caused or contributed significantly to the adverse event,and if they occurred within 30 days of the procedure, they would be considered major adverse events (MAEs). Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. | Posted | Number | participants | 30 days |
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| Secondary | Primary Assisted Patency | Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
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| Secondary | Secondary Patency | Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency. | Posted | Number | 95% Confidence Interval | percentage of subjects | 12 months |
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| Secondary | Device-related Major Adverse Events at 12 Months | If the functioning or characteristics of the device caused or contributed significantly to the adverse event (AE), the AE would be related to the device. Major AEs require significant therapy, including an unplanned increase in the level of care, permanent sequelae, hospitalization, or death. | Posted | Number | event | 12 months |
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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 | Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface | Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface | 11 | 119 | 0 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction, unspecified site | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Death | General disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
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| Chronic renal failure | Renal and urinary disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Claudication | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Femoral artery embolism | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Ischemic leg ulcer | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Thrombosis in device | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
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The investigator will provide the materials to the sponsor at least 30 days in advance of submission for publication or public disclosure. The sponsor has the right to make modifications as necessary to protect proprietary information or correct inaccuracies in technical specifications or device descriptions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chad Badorek | W. L. Gore & Associates, Inc. | 928/437-8181 | cbadorek@wlgore.com |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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