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To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Active Comparator |
| |
| Bare Nitinol Stent (BNS) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE VIABAHN Endoprosthesis | Device | Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Primary Patency at Three Years | Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years). | 3 years |
| Safety: Composite of Major Procedural (30-day) Adverse Events (AEs) | Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Assisted Patency | Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion. | 3 years |
| Secondary Patency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Ansel, MD | Midwest Cardiology | Principal Investigator |
| Patrick Geraghty, MD | Washington University School of Medicine | Principal Investigator |
| Mark Mewissen, MD | St. Luke's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Phoenix | Phoenix | Arizona | 85054 | United States | ||
| Arkansas Heart |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23676191 | Derived | Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013 Aug;58(2):386-95.e4. doi: 10.1016/j.jvs.2013.01.050. Epub 2013 May 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE VIABAHN Endoprosthesis | Subjects randomized to this group received the Gore VIABAHN Endoprosthesis. |
| FG001 | Bare Nitinol Stent | Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bare Nitinol Stent | Device | Implantation |
|
Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
| 3 years |
| Technical Success at Initial Procedure | Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow. The results show the percentage of study subjects that had technical success. | Time of implant procedure |
| Target Vessel Revascularization (TVR) | This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study. | 3 years |
| Target Lesion Revascularization (TLR) | This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study. | 3 years |
| Improvement in Rutherford Classification (Clinical Success) | The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 3 years |
| Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire. Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline. | 3 years |
| Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline. | 3 years |
| Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline. | 3 years |
| Change in Ankle-Brachial Index (ABI) | This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal. An outcome of a higher mean ABI is considered a success. | 3 years |
| Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) | The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5. | 3 years |
| Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) | The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0. | 3 years |
| Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays. | 1 year |
| Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays. | 2 years |
| Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays. | 3 years |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Vascular Surgical Associate | Austell | Georgia | 30106 | United States |
| Midwest Heart Foundation | Lombard | Illinois | 60148 | United States |
| Midwest Institute for Minimally Invasive Therapy | Melrose Park | Illinois | 60160 | United States |
| St Francis Medical Center | Peoria | Illinois | 61637 | United States |
| St. Johns Hospital/Prairie Education Research | Springfield | Illinois | 62701 | United States |
| Ochsner Clinic | New Orleans | Louisiana | 70121 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Midwest Cardiology Research Foundation | Columbus | Ohio | 43214 | United States |
| Heritage Valley Health Systems | Beaver | Pennsylvania | 15009 | United States |
| Allegheney General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| St Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Baseline |
|
| 30-Day Follow-up (Safety Outcome) |
|
| Three Year Follow-up (Final) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE VIABAHN Endoprosthesis | Subjects randomized to this group received the Gore VIABAHN Endoprosthesis. |
| BG001 | Bare Nitinol Stent | Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Efficacy: Primary Patency at Three Years | Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years). | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
|
|
| |||||||||||||||||||||||||||||
| Primary | Safety: Composite of Major Procedural (30-day) Adverse Events (AEs) | Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations. | Posted | Number | percentage of subjects | 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Primary Assisted Patency | Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion. | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Secondary Patency | Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment. | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Technical Success at Initial Procedure | Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow. The results show the percentage of study subjects that had technical success. | The number of participant analyzed were those for which we had data. Not all sites recorded both measures required to calculate technical success. | Posted | Number | percentage of subjects | Time of implant procedure |
|
| ||||||||||||||||||||||||||||||
| Secondary | Target Vessel Revascularization (TVR) | This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study. | Posted | Number | percentage of participants | 3 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Target Lesion Revascularization (TLR) | This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study. | Posted | Number | percentage of participants | 3 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Improvement in Rutherford Classification (Clinical Success) | The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | The number of participants analyzed was the number of subjects that returned for the 3yr follow-up visit and for which we had data. | Posted | Number | percentage of participants | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire. Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline. | Number of subjects that returned for 3yr follow-up appointment and completed the ICQ. | Posted | Mean | Standard Deviation | Score | 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline. | The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment. | Posted | Mean | Standard Deviation | Score | 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline. | The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the assessment. | Posted | Mean | Standard Deviation | Score | 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Ankle-Brachial Index (ABI) | This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal. An outcome of a higher mean ABI is considered a success. | The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and had the ABI completed and recorded. | Posted | Mean | Standard Deviation | ABI Value | 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) | The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 2.5. | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) | The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that had a PSVR of equal or less than 3.0. | Posted | Number | 95% Confidence Interval | percentage of subjects | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays. | The number of participants analyzed is the number of subjects that returned for the 1yr follow-up and completed the X-ray assessment. | Posted | Number | percentage of particpants | 1 year |
|
| ||||||||||||||||||||||||||||||
| Secondary | Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays. | The number of participants analyzed is the number of subjects that returned for the 2yr follow-up and completed the X-ray assessment. | Posted | Number | percentage of participants | 2 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays. | The number of participants analyzed is the number of subjects that returned for the 3yr follow-up and completed the X-ray assessment. | Posted | Number | percentage of participants | 3 years |
|
|
Throughout three-year study
At each scheduled and unscheduled visit, subjects were asked about their health and if there were any changes to baseline. If so, this was recorded on a Case Report Form and reported to the Sponsor.
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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 | GORE VIABAHN Endoprosthesis | 25 | 72 | 6 | 72 | ||
| EG001 | Bare Nitinol Stent | Bare Nitinol Stent | 24 | 76 | 4 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Acute chest pain | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cardiomyopathy NOS | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Chest burning | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Congestive cardiac failure aggravated | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Non-Q wave MI | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pulmonary edema | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
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| GI bleed | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Internal hemorrhoids | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Acute chest pain | General disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Implantable defibrillator malfunction | General disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Thrombosis in device | General disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Acute bronchitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Acute gastroenteritis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Acute pyelonephritis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Bronchitis NOS | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Candida oesophagitis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cellulitis gangrenous | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cellulitis of foot | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cellulitis of hand | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Cellulitis of leg | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Influenza A virus infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Osteomyelitis NOS | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Septicemia due to Escherichia coli (E. coli) | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Staphylococcal septicemia | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 14.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Incision site infection | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
| |
| Back pain (with radiation) | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Calf pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture L2 | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pain of lower extremities | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Bladder cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
| |
| Small cell carcinoma of the lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
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| Subarachnoid hemorrhage | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Unilateral carpal tunnel syndrome | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Acute renal insufficiency | Renal and urinary disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Chronic renal insufficiency | Renal and urinary disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| AV fistula creation | Surgical and medical procedures | MedDRA Version 14.0 | Systematic Assessment |
| |
| Enucleation of eyeball | Surgical and medical procedures | MedDRA Version 14.0 | Systematic Assessment |
| |
| Claudication | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Coronary artery disease | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Coronary heart disease | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Critical limb ischemia | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| In-stent arterial restenosis | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Ischemic ulcer | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Leg ischemia | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Superficial femoral arterial stenosis | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Vessel puncture site thrombosis | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site hematoma | General disorders | MedDRA Version 14.0 | Systematic Assessment |
| |
| Claudication | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
|
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. | 800/437-8181 | cbadorek@wlgore.com |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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