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To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indigo Aspiration System | Device | use of mechanical thrombectomy to treat pulmonary embolism |
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| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricle/Left Ventricle (RV:LV) Ratio | Change in RV/LV ratio per CTA | from baseline to 48 hours |
| Major Adverse Event Rate | A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury) | within 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related Death Rate | within 48 hours | |
| Major Bleeding Rate | within 48 hours | |
| Clinical Deterioration Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akhilesh Sista, MD | NYU-Langone School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36888834 | Derived | Jorge JV, Barreiros CA, Silva D, Cale R, Ribeiro JM. Extracorporeal mechanical support and aspiration thrombectomy in treatment of massive pulmonary embolism: a case report. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):524-528. doi: 10.5935/0103-507X.20220342-pt. Epub 2023 Mar 3. | |
| 33454291 | Derived | Sista AK, Horowitz JM, Tapson VF, Rosenberg M, Elder MD, Schiro BJ, Dohad S, Amoroso NE, Dexter DJ, Loh CT, Leung DA, Bieneman BK, Perkowski PE, Chuang ML, Benenati JF; EXTRACT-PE Investigators. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021 Feb 8;14(3):319-329. doi: 10.1016/j.jcin.2020.09.053. Epub 2021 Jan 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indigo Aspiration System | Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism |
| 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 | Jun 12, 2018 | Feb 24, 2020 |
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| within 48 hours |
| Pulmonary Vascular Injury Rate | within 48 hours |
| Cardiac Injury Rate | within 48 hours |
| Any-cause Mortality | within 30 days |
| Device-related SAE Rate | within 30 days |
| Symptomatic PE Recurrence Rate | within 30 days |
| Los Angeles |
| California |
| 90048 |
| United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| St. Joseph Health Hospital | Orange | California | 92868 | United States |
| Christiana Care | Newark | Delaware | 19713 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Our Lady of the Lake Hospital Inc. | Baton Rouge | Louisiana | 70808 | United States |
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| New York University (NYU) Langone Medical Center | New York | New York | 10016 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| North Carolina Heart and Vascular Research (NCHVR) | Raleigh | North Carolina | 27607 | United States |
| University of Pennsylvania Medical Center (UPMC) | Pittsburgh | Pennsylvania | 16148 | United States |
| Sanford Health | Sioux Falls | South Dakota | 57117 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Charleston Area Medical Center (CAMC) | Charleston | West Virginia | 25309 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BMI-Females | BMI specific to female population. | Mean | Standard Deviation | kg/m^2 |
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| BMI-Males | BMI specific to male population. | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Right Ventricle/Left Ventricle (RV:LV) Ratio | Change in RV/LV ratio per CTA | The intent-to-treat population calculating the change between the baseline and the 48 hours RV/LV diameter ratio | Posted | Mean | Standard Deviation | Change in RV/LV Diameter Ratio | from baseline to 48 hours |
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| Primary | Major Adverse Event Rate | A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury) | Posted | Count of Participants | Participants | within 48 hours |
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| Secondary | Device-related Death Rate | Posted | Count of Participants | Participants | within 48 hours |
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| Secondary | Major Bleeding Rate | Posted | Count of Participants | Participants | within 48 hours |
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| Secondary | Clinical Deterioration Rate | Posted | Count of Participants | Participants | within 48 hours |
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| Secondary | Pulmonary Vascular Injury Rate | Posted | Count of Participants | Participants | within 48 hours |
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| Secondary | Cardiac Injury Rate | Posted | Count of Participants | Participants | within 48 hours |
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| Secondary | Any-cause Mortality | Posted | Count of Participants | Participants | within 30 days |
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| Secondary | Device-related SAE Rate | Posted | Count of Participants | Participants | within 30 days |
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| Secondary | Symptomatic PE Recurrence Rate | Posted | Count of Participants | Participants | within 30 days |
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Within 30 days post-procedure
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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 | Single Arm | Single Arm - Use of Indigo Aspiration System (mechanical thrombectomy) to treat pulmonary embolism Indigo Aspiration System: use of mechanical thrombectomy to treat pulmonary embolism | 3 | 119 | 13 | 119 | 56 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory Arrest | Cardiac disorders | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Vascular Access Site Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Ovarian Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | Systematic Assessment |
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| Stroke in Evolution | Nervous system disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Extrasystoles | Cardiac disorders | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | Systematic Assessment |
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| Abnormal Faeces | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Crohn's Disease | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hernia | General disorders | Systematic Assessment |
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| Oedema Peripheral | General disorders | Systematic Assessment |
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| Vessel Puncture Site Pain | General disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Fungal Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Alcohol Poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Craniocerebral injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular Access Site Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest wall haematoma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Limb Discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Unresponsive To Stimuli | Nervous system disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Infarction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sputum Discoloured | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Archard, Sr. Clinical Study Manager | Penumbra, Inc. | +1 510 995 9801 | earchard@penumbrainc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2019 | Feb 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Unknown or Not Reported |
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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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