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Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abre | Experimental | Abre Venous Self-expanding Stent System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abre venous self-expanding stent system | Device | venous stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency | Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization | 12 Months |
| Composite Major Adverse Events | The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure. | Index Procedure |
| Lesion Success Obtained at Index Procedure |
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Inclusion Criteria:
Patient is ≥ 18 and ≤ 80 years of age;
Patient has at least one of the following clinical manifestations (i.e. symptoms and/or signs) of venous disease in lower extremity:
Patient is willing and capable of complying with specified follow-up evaluations at the specified times;
Patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Board.
Patient has diagnosis of non-malignant venous obstruction within the common iliac, external iliac, and/or common femoral vein. The proximal point of the obstruction may extend to the iliac venous confluence of the inferior vena cava and the distal point may be at or above the deep femoral vein. Diagnosis must be made based on objective imaging by using venography and/or intravascular ultrasound (IVUS);
Patient has an obstructive lesion defined as:
Acute DVT patients should be treated with the Abre stent within 14 days after onset of symptoms. Patients with acute DVT must first undergo successful treatment of acute thrombus by catheter based techniques; successful treatment is defined as 30% or less residual thrombus by venogram, as determined by physician, no bleeding, no symptomatic pulmonary embolism (confirmed by imaging), and no renal compromise (renal compromise defined as GFR>30). Patients with underlying obstructive lesions can then be included in the study within the same procedure;
Target vessel can accommodate a 9 French Sheath, from insertion site to target segment;
Exchangeable guidewire must cross target lesion(s) with successful predilation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Murphy, MD | Carolinas Health Care System | Principal Investigator |
| Stephen Black, MD | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital | Orange | California | 92868 | United States | ||
| The Vascular Experts |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35105153 | Derived | Murphy E, Gibson K, Sapoval M, Dexter DJ, Kolluri R, Razavi M, Black S. Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010960. doi: 10.1161/CIRCINTERVENTIONS.121.010960. Epub 2022 Feb 2. |
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Of the 260 enrolled subjects, 200 met inclusion criteria and were implanted with the Abre stent(s).
Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between December 2017 and November 2018. Included subjects went on to have one or more Abre stents implanted. The first subject was included on December 19, 2017 and the last subject was included on November 29, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABRE | Subjects implanted with one or more Abre stents. |
| 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 | Mar 2, 2021 | Nov 2, 2021 |
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Venographic evidence of <50% residual stenosis of the stented segment of the target lesion after post-dilation.
| Index Procedure |
| Index Procedure Success | Lesion success without procedure-related MAEs prior to hospital discharge | 30 days |
| Primary Patency | Primary Patency: Defined as meeting all of the following criteria:
| 24 Months, 36 Months |
| Primary Assisted Patency | Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.) | 12 Months, 24 Months, 36 Months |
| Secondary Patency | Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion. | 12 Months, 24 Months, 36 Months |
| Stent Fracture | X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively. | 30 Days, 12 Months, 24 Months, 36 Months |
| Target Lesion Revascularization | Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days. | 30 days, 6 months, 12 months, 24 months, 36 months |
| Delayed Stent Migration | Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively. | 12 Months, 24 Months, 36 Months |
| Major Adverse Events | Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit. | 6 Months, 12 Months, 24 Months, 36 Months |
| Major Bleeding Related to Index Procedure | A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure. | 30 Days, 6 Months, 12 Months, 24 Months, 36 Months |
| Re-Hospitalization | Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure. | 0-180, 181-360, 361-720, 721-1080 and 0-1080 days |
| Villalta Score | Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A negative change is associated with improved outcome. | Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
| Venous Clinical Severity Score (VCSS) | VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score. A negative change is associated with improved outcome. | Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
| EuroQol-5 Dimension (EQ-5D) Score | Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores. | Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
| Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A positive change is associated with improved outcome. | Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
| Darien |
| Connecticut |
| 06820 |
| United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| The Mount Sinai Health System | New York | New York | 10029 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27607 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| Cardiac Center of Texas | McKinney | Texas | 75069 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Lake Washington Vascular, PLLC | Bellevue | Washington | 98004 | United States |
| Assistance Publique - Hôpitaux de Marseille - Hôpital Nord | Marseille | 13915 | France |
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| Universitätsklinikum Aachen | Aachen | D-52074 | Germany |
| Klinikum Arnsberg, Karolinen Hospital | Arnsberg | D-59759 | Germany |
| Galway University Hospitals - University Hospital Galway | Galway | H91 YR71 | Ireland |
| Hesperia Hospital | Modena | 41125 | Italy |
| University College London Hospitals NHS Foundation Trust - University College London Hospitals | London | NW1 2PG | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital | London | SE1 7EH | United Kingdom |
| 30-Day Follow-Up |
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| 6-Month Follow-up |
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| 12-Month Follow-up |
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| 24-Month Follow-up |
|
| 36-Month Follow-up |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABRE | Subjects included and implanted with one or more Abre stents |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Freedom from occlusion of the stented segment; Freedom from restenosis >=50%; and Freedom from clinically-driven target lesion revascularization | Proportion Rate | Posted | Count of Participants | Participants | 12 Months |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Composite Major Adverse Events | The components of the Major Adverse Events include: All-cause death occurring post-procedure, clinically-significant pulmonary embolism, major bleeding complication, stent thrombosis, and stent migration | Proportion Rate | Posted | Count of Participants | Participants | 30 Days |
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| Secondary | Device Success | Successful delivery and deployment of the stent and removal of the delivery system during the index procedure. Stent based outcome measure. | 302 Abre stents were implanted in 200 included subjects. | Posted | Count of Units | Implanted Stents | Index Procedure | Implanted Stents | Implanted Stents |
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| Secondary | Lesion Success Obtained at Index Procedure | Venographic evidence of <50% residual stenosis of the stented segment of the target lesion after post-dilation. | Posted | Count of Participants | Participants | Index Procedure |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Index Procedure Success | Lesion success without procedure-related MAEs prior to hospital discharge | Posted | Count of Participants | Participants | 30 days |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Primary Patency | Primary Patency: Defined as meeting all of the following criteria:
| SURVIVAL estimate using Kaplan-Meier method. Estimate made at 720 and 1080 days. | Posted | Number | Event-Free % | 24 Months, 36 Months |
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| Secondary | Primary Assisted Patency | Uninterrupted patency of the stented segment of the target lesion with a secondary intervention, also known as an adjunctive treatment (e.g. balloon venoplasty, subsequent stenting, etc.) | SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days. | Posted | Number | Event-Free % | 12 Months, 24 Months, 36 Months |
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| Secondary | Secondary Patency | Secondary patency is defined as patency of the stented segment of the target lesion after subsequent intervention for an occlusion. | SURVIVAL estimate using Kaplan-Meier method. Estimate made at 360, 720, and 1080 days. | Posted | Number | Event-Free % | 12 Months, 24 Months, 36 Months |
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| Secondary | Stent Fracture | X-ray for the 30-day visit was only required on the first 30 subjects. Stent Fracture within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1080, respectively. | X-ray for the 30-day visit was only required on the first 30 subjects; included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to 420 days for 12 months assessment, up to 780 days for 24 months assessment, and up to 1140 days for 36 months assessment. | Posted | Number | Stents | 30 Days, 12 Months, 24 Months, 36 Months | Stents | Stents |
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| Secondary | Target Lesion Revascularization | Percentage of subjects with target lesion revascularization through 30 days, 180 days, 360 days, 720, and 1080 days. | Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 30, 180, 360, 720, and 1080 days. | Posted | Number | Event % | 30 days, 6 months, 12 months, 24 months, 36 months |
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| Secondary | Delayed Stent Migration | Delayed Stent Migration within 12, 24, and 36 months included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging up to day 420, 780, and 1140, respectively. | Included subjects who had scheduled visit-based evaluable imaging and unscheduled imaging | Posted | Number | Stent number | 12 Months, 24 Months, 36 Months | Stents | Stents |
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| Secondary | Major Adverse Events | Safety endpoints (MAE, TLR, and Major Bleeding) included subjects with an event or without an event but follow-up days have reached 150 days for 6-month, 330 days for 12-month, 690 days for 24-month, and 1050 days for 36-month visit. | Cumulative incidence estimate using Kaplan-Meier method. Estimate made at 180, 360, 720, and 1080 days. | Posted | Number | Event % | 6 Months, 12 Months, 24 Months, 36 Months |
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| Secondary | Major Bleeding Related to Index Procedure | A blood loss leading to transfusion of whole blood or red cells provided hemoglobin drop of 3 g/dL (1.86 mmol/L) or more post-index procedure is related to bleeding occurring during the index procedure. | Subjects with an event or a minimum number of follow-up days per time point. | Posted | Count of Participants | Participants | 30 Days, 6 Months, 12 Months, 24 Months, 36 Months |
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| Secondary | Re-Hospitalization | Number of subjects that were re-hospitalized due to their target lesion from the Index Procedure. | Subjects with an event or a minimum number of follow-up days per time point. | Posted | Count of Participants | Participants | 0-180, 181-360, 361-720, 721-1080 and 0-1080 days |
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| Secondary | Villalta Score | Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, severe PTS. Change in Villalta scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A negative change is associated with improved outcome. | Subjects with available data at time point | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
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| Secondary | Venous Clinical Severity Score (VCSS) | VCSS scores range from 0=no disease to 30=severe disease. Change in VCSS score was calculated as the Follow-up score minus the Baseline score. A negative change is associated with improved outcome. | Subjects with available data at time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
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| Secondary | EuroQol-5 Dimension (EQ-5D) Score | Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0 = worst health; 100 = best health). A positive change is associated with improved outcome. Change in EQ-5D scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, and 24 months) for both the index and VAS scores. | Subjects with available data at time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
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| Secondary | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym) Score | Venous Insufficiency Epidemiological and Economic Study (VEINES) - Quality of Life/Symptoms (QOL/Sym). Higher scores correlate to better quality of life on a scale of 1-100. Change in VEINES QOL/Sym scores were calculated as the Follow-up score minus the Baseline score (6, 12, 24, or 36 months). A positive change is associated with improved outcome. | Subjects with available data at time point. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 6 Months, 12 Months, 24 Months, 36 Months |
|
|
Through 1080 Days
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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 | ABRE | Subjects implanted with one or more Abre stents. | 3 | 200 | 86 | 200 | 17 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ACUTE LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| BRADYCARDIA | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| BRCA2 GENE MUTATION | Congenital, familial and genetic disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ABDOMINAL WALL HAEMATOMA | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ANAL FISSURE | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| RETROPERITONEAL HAEMATOMA | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| PERIPHERAL SWELLING | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR STENT OCCLUSION | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR STENT STENOSIS | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR STENT THROMBOSIS | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| INTERVERTEBRAL DISCITIS | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR ACCESS SITE HAEMATOMA | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR ACCESS SITE HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR GRAFT OCCLUSION | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| INTERVERTEBRAL DISC DEGENERATION | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| NONKERATINISING CARCINOMA OF NASOPHARYNX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| PARATHYROID TUMOUR BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| CERVICAL RADICULOPATHY | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| DEMENTIA ALZHEIMER'S TYPE | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| INTRACRANIAL ANEURYSM | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| MYELOPATHY | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| VASCULAR DEMENTIA | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
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| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
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| HEAVY MENSTRUAL BLEEDING | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
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| INTERMENSTRUAL BLEEDING | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
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| UTEROVAGINAL PROLAPSE | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| STASIS DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| COLLATERAL CIRCULATION | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| LYMPHOEDEMA | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| PERIPHERAL ARTERY OCCLUSION | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| PERIPHERAL ARTERY STENOSIS | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| PERIPHERAL VEIN STENOSIS | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| PERIPHERAL VENOUS DISEASE | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| VARICOSE VEIN | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| VENA CAVA THROMBOSIS | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| VENOUS HAEMORRHAGE | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Cihlar | Medtronic | 763.258.9524 | stephanie.a.cihlar@medtronic.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 14, 2020 | Jan 4, 2021 | SAP_001.pdf |
Not provided
| Unknown or Not Reported |
|
| 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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| United Kingdom |
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| Italy |
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| France |
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| Germany |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 12 Months |
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| 24 Months |
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| 36 Months |
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| Title | Denominators | Categories |
|---|
| 12 Month |
| |||||
| 24 Months |
| |||||
| 36 Months |
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| Stents |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 30 Days |
| |||||
| 6 Months |
| |||||
| 12 Months |
| |||||
| 24 Months |
| |||||
| 36 Months |
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| Stents |
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| Title | Denominators | Categories |
|---|
| 0-6 Months |
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| 6-12 Months |
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| 12-24 Months |
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| 24-36 Months |
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| 0-36 Months |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Change from Baseline to 6 Months |
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| Change from Baseline to 12 Months |
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| Change from Baseline to 24 Months |
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| Change from Baseline to 36 Months |
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