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The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Other | Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness | Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis. | 12 Months |
| Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure | Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Acute Procedural Success | Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge. | During hospitalization, approximately 1-2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Soukas, MD | Miriam Hospital, Providence, RI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Medical Center | Miami | Florida | 33140 | United States | ||
| Kaiser Foundation Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gore VIABAHN Endoprosthesis | Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery Gore VIABAHN Endoprosthesis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2015 | Jul 15, 2020 |
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| Primary Patency at 30 Days and 12, 24, and 36 Months |
Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention. |
| 30 days and 12, 24, and 36 months |
| Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion. | 30 days and 12, 24, and 36 months |
| Secondary Patency at 30 Days and 12, 24, and 36 Months | Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion. | 30 days and 12, 24, and 36 months |
| Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency. | 30 days and 12, 24, and 36 months |
| Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event. | 30 days and 12, 24, and 36 months |
| Change in Ankle Brachial Index at 30 Days | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 30 Days |
| Change in Ankle Brachial Index at 1 Year | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 1 Year |
| Change in Ankle Brachial Index at 2 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 2 Years |
| Change in Ankle Brachial Index at 3 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Pre-procedure and 3 Years |
| Change in Rutherford Category at 30 Days | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 30 Days |
| Change in Rutherford Category at 1 Year | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 1 Year |
| Change in Rutherford Category at 2 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 2 Years |
| Change in Rutherford Category at 3 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Pre-procedure and 3 Years |
| Stent Fracture at 12, 24, and 36 Months | Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images. | 12, 24, and 36 months |
| Honolulu |
| Hawaii |
| 96819 |
| United States |
| Rockford CardioVascular Associates | Rockford | Illinois | 61107 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70360 | United States |
| Covenant Medical Center, Inc. | Saginaw | Michigan | 48602 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Midwest Aortic and Vascular Institute (MAVI) | North Kansas City | Missouri | 64116 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| New York Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| North Carolina Heart and Vascular | Raleigh | North Carolina | 27607 | United States |
| Sanford Health | Fargo | North Dakota | 58122 | United States |
| Providence Heart Clinic | Portland | Oregon | 97225 | United States |
| St. Vincent's Consultants in Cardiovascular Disease | Erie | Pennsylvania | 16502 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29615 | United States |
| Texas Health Research - Presbyterian Heart and Vascular | Dallas | Texas | 75231 | United States |
| Texas Health Research - Presbyterian Hospital of Plano | Plano | Texas | 75093 | United States |
| Swedish Medical Center - Heart and Vascular Research | Seattle | Washington | 98122 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| Klinikum Rosenheim | Rosenheim | Germany |
| Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia | Reggio Emilia | Italy |
| Skånes Universitetssjukhus | Malmö | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gore VIABAHN Endoprosthesis | Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery Gore VIABAHN Endoprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Race only collected among U.S. study subjects. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Rutherford Category | Lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | Count of Participants | Participants |
| |||||||||||||||||
| Ankle Brachial Index (ABI) | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values range from 0 to >1, with smaller values indicating more severe obstruction and larger values indicating better blood flow. | Data missing or unknown/not measured. | Mean | Standard Deviation | Ratio |
|
| 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 Effectiveness | Primary Effectiveness is Primary Patency defined as patent blood flow through the study device, which requires either a Peak Systolic Velocity Ratio measurement ≤ 2.5 or patent flow indicated by the Core Lab, and without repeat intervention measured at 12 months and assessed by Kaplan-Meier analysis. | Posted | Number | 95% Confidence Interval | Probability | 12 Months |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Subjects Free From Procedure and Device-Related Serious Adverse Events Within 30 Days of Index Procedure | Primary Safety is defined as freedom from procedure and device-related serious adverse events within 30 days of index procedure | Posted | Count of Participants | Participants | 30 Days |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Acute Procedural Success | Acute Procedural Success is defined as successful delivery of the study device and complete coverage of the target lesion without a procedure or device-related Serious Adverse Event prior to hospital discharge. | Posted | Count of Participants | Participants | During hospitalization, approximately 1-2 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Primary Patency at 30 Days and 12, 24, and 36 Months | Primary patency is defined as patent blood flow through the study device, which requires either a PSVR measurement ≤ 2.5 or patent flow indicated by the Core Lab, without repeat intervention. | Posted | Number | 95% Confidence Interval | Probability | 30 days and 12, 24, and 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Primary Assisted Patency at 30 Days and 12, 24, and 36 Months | Primary assisted patency is defined as blood flow through the study device regardless of repeat interventions to maintain patency prior to occlusion. | Posted | Number | 95% Confidence Interval | Probability | 30 days and 12, 24, and 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Secondary Patency at 30 Days and 12, 24, and 36 Months | Secondary patency is defined as blood flow through the study device regardless of repeat interventions to restore patency after occlusion. | Posted | Number | 95% Confidence Interval | Probability | 30 days and 12, 24, and 36 months |
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| |||||||||||||||||||||||||||
| Secondary | Freedom From Target Lesion Revascularization at 30 Days and 12, 24, and 36 Months | Target Lesion Revascularization is defined as a repeat intervention within the study device and 5 mm proximal or distal to the edge of the study device to maintain or re-establish patency. | Posted | Number | 95% Confidence Interval | Probability | 30 days and 12, 24, and 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Freedom From Major Amputation at 30 Days and 12, 24, and 36 Months | Major Amputation is defined as removal of the study limb above the metatarsals, resulting from a vascular event. | Posted | Number | 95% Confidence Interval | Probability | 30 days and 12, 24, and 36 months |
|
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| Secondary | Change in Ankle Brachial Index at 30 Days | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 30 days. | Posted | Mean | Standard Deviation | ratio | Pre-procedure and 30 Days |
|
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| Secondary | Change in Ankle Brachial Index at 1 Year | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 1 year. | Posted | Mean | Standard Deviation | ratio | Pre-procedure and 1 Year |
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| Secondary | Change in Ankle Brachial Index at 2 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 2 Years. | Posted | Mean | Standard Deviation | ratio | Pre-procedure and 2 Years |
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| Secondary | Change in Ankle Brachial Index at 3 Years | The Ankle Brachial Index (ABI) is the ankle systolic pressure in the study limb divided by the highest systolic pressure in either arm. ABI values <= 0.90 are considered abnormal, 0.91-0.99 borderline, 1.00-1.40 normal, and >1.40 noncompressible. The change in ABI was measured relative to that obtained pre-procedure. | Includes all subjects with Ankle Brachial Index values measured at both pre-procedure and 3 Years. | Posted | Mean | Standard Deviation | ratio | Pre-procedure and 3 Years |
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| Secondary | Change in Rutherford Category at 30 Days | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Includes all subjects with Rutherford Category measured at both pre-procedure and 30 days. | Posted | Mean | Standard Deviation | units on a scale | Pre-procedure and 30 Days |
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| Secondary | Change in Rutherford Category at 1 Year | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Includes all subjects with Rutherford Category measured at both pre-procedure and 1 year. | Posted | Mean | Standard Deviation | units on a scale | Pre-procedure and 1 Year |
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| Secondary | Change in Rutherford Category at 2 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Includes all subjects with Rutherford Category measured at both pre-procedure and 2 years. | Posted | Mean | Standard Deviation | units on a scale | Pre-procedure and 2 Years |
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| Secondary | Change in Rutherford Category at 3 Years | The Rutherford Category is a lower limb ischemia classification with 7 categories ranging from least severe (category 0) to most severe (category 6): Category 0 - No claudication; Category 1 - Mild claudication; Category 2 - Moderate claudication; Category 3 - Severe claudication; Category 4 - Ischemic rest pain; Category 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia; Category 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable. The change is Rutherford Category was measured relative to that obtained pre-procedure and a negative change corresponds to improved outcome. | Includes all subjects with Rutherford Category measured at both pre-procedure and 3 years. | Posted | Mean | Standard Deviation | units on a scale | Pre-procedure and 3 Years |
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| Secondary | Stent Fracture at 12, 24, and 36 Months | Device stent fractures that are clearly distinguishable from previously implanted stents will be assessed by the study core lab through x-ray images. | Includes all subjects who had x-ray or angiographic data to determine device stent fracture at the reported corresponding follow-up time period.. | Posted | Count of Participants | Participants | 12, 24, and 36 months |
|
|
36 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 | Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery Gore VIABAHN Endoprosthesis | 13 | 108 | 70 | 108 | 30 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Atrial fibrillation with rapid ventricular response | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Atrioventricular junctional escape rhythm | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Congestive cardiac failure aggravated | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Decompensation cardiac | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Non ST segment elevation myocardial infarction | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Non STEMI | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Paroxysmal atrial fibrillation | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Sick sinus syndrome | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Triple vessel disease | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Unstable angina | Cardiac disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Colon stenosis | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Esophageal ulcer | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Gastrointestinal bleed | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Lower gastrointestinal bleeding | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Retroperitoneal bleed | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Delayed healing of wound | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| In-stent arterial restenosis | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| In-stent arterial stenosis | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Unknown cause of death | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Vessel puncture site hematoma | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Weakness | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Wound healing delayed | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Acute cholecystitis | Hepatobiliary disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Bile duct stricture | Hepatobiliary disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Bilateral pneumonia | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Cellulitis genital organ (male) | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Cellulitis of leg | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Febrile infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Gangrene peripheral | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Infectious diarrhea | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Influenza A virus infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Influenza B virus infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Osteomyelitis of the foot | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Broken bones | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Drug overdose accidental | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Fractured hip | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Jaw fracture | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 24.0 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Systematic Assessment |
| |
| Malignant neoplasm of hypopharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Systematic Assessment |
| |
| Urothelial carcinoma urethra | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Cerebral hemorrhage | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Cerebral infarct | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Grand mal seizure | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Hemiparesis (left) | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Internal carotid artery stenosis | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Ischemic stroke | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Near syncope | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Seizures | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Tremor aggravated | Nervous system disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA Version 24.0 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA Version 24.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Acute kidney failure | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Acute retention of urine | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Acute on chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Pulmonary necrotizing granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Foot ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Acute limb ischemia | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Atherosclerosis | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Critical limb ischemia | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| In-stent arterial restenosis | General disorders | MedDRA Version 24.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA Version 24.0 | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA Version 24.0 | Systematic Assessment |
|
Institution and Investigator agree not to submit any Publication until Study Completion and the multi-center Publication has been published. If the multi-center Publication has not been submitted within 12 months of Study Completion, Institution and Investigator may be able to proceed with submission of the Publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Novak | W. L. Gore & Associates | 314-440-2119 | enovak@wlgore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2015 | Jul 15, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Italy |
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| Sweden |
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| Category 1 |
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| Category 2 |
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| Category 3 |
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| Category 4 |
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| Category 5 |
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| Category 6 |
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
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| 30 Day |
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| 12 Month |
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| 24 Month |
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| 36 Month |
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| 30 Day |
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| 12 Month |
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| 24 Month |
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| 36 Month |
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| Title | Denominators | Categories | ||||
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| 12 Month |
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| 24 Month |
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| 36 Month |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 30 Day |
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| 12 Month |
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| 24 Month |
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| 36 Month |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 30 Day |
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| 12 Month |
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| 24 Month |
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| 36 Month |
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