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The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indigo Aspiration System | Device | Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite of: | Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Final TIMI Flow Grade | TIMI flow grading range 0-3, with higher grading representing better outcome | Procedure |
| Final TIMI Thrombus Grade | TIMI Thrombus grading range 0-5, with lower grading representing better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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High thrombus burden patients presenting with acute coronary vessel occlusion who are referred for standard of care (SOC) PCI
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| Name | Affiliation | Role |
|---|---|---|
| S. Jay Mathews, MD | Manatee Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| St. Joseph Hospital - Orange |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4 |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 6, 2019 |
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| Procedure |
| Myocardial Blush Grade | Myocardial blush grading range 0-3, with higher grading representing better outcome | Procedure |
| Distal Embolization Rate | Procedure |
| Stent Thrombosis | 180 Days |
| Stroke | 30 Days |
| Major Bleeding | 30 Days |
| All-Cause Mortality | 180 Days |
| Cardiovascular Death | 180 Days |
| Recurrent MI | 180 Days |
| Cardiogenic Shock | 180 Days |
| Class IV Heart Failure | 180 Days |
| Incident of Device Related SAEs | 180 Days |
| Orange |
| California |
| 92868 |
| United States |
| UCSD Medical Center | San Diego | California | 92103 | United States |
| Manatee Memorial Hospital | Bradenton | Florida | 34208 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| Largo Medical Center | Largo | Florida | 33770 | United States |
| AdventHealth Tampa (Florida Hospital Tampa) | Tampa | Florida | 33613 | United States |
| Mercy Medical Des Moines | Des Moines | Iowa | 50314 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| St. John Hospital | Detroit | Michigan | 48236 | United States |
| Metro Health Hospital | Grand Rapids | Michigan | 49519 | United States |
| Metropolitan Heart & Vascular | Coon Rapids | Minnesota | 55433 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Desert Springs Hospital | Las Vegas | Nevada | 89119 | United States |
| University at Buffalo Medical Center | Buffalo | New York | 14260 | United States |
| NYU Langone | New York | New York | 10016 | United States |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | United States |
| Mercy West Hospital | Cincinnati | Ohio | 45211 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| Turkey Creek Medical Center | Knoxville | Tennessee | 37934 | United States |
| Kingwood Medical Center | Kingwood | Texas | 77339 | United States |
| Sentara Norfolk General | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of: | Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Final TIMI Flow Grade | TIMI flow grading range 0-3, with higher grading representing better outcome | Posted | Count of Participants | Participants | Procedure |
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| Secondary | Final TIMI Thrombus Grade | TIMI Thrombus grading range 0-5, with lower grading representing better outcome | Posted | Count of Participants | Participants | Procedure |
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| Secondary | Myocardial Blush Grade | Myocardial blush grading range 0-3, with higher grading representing better outcome | Posted | Count of Participants | Participants | Procedure |
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| Secondary | Distal Embolization Rate | Posted | Count of Participants | Participants | Procedure |
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| Secondary | Stent Thrombosis | Posted | Count of Participants | Participants | 180 Days |
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| Secondary | Stroke | Posted | Count of Participants | Participants | 30 Days |
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| Secondary | Major Bleeding | Posted | Count of Participants | Participants | 30 Days |
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| Secondary | All-Cause Mortality | Posted | Count of Participants | Participants | 180 Days |
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| Secondary | Cardiovascular Death | Posted | Count of Participants | Participants | 180 Days |
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| Secondary | Recurrent MI | Posted | Count of Participants | Participants | 180 Days |
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| Secondary | Cardiogenic Shock | Posted | Count of Participants | Participants | 180 Days |
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| Secondary | Class IV Heart Failure | Posted | Count of Participants | Participants | 180 Days |
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| Secondary | Incident of Device Related SAEs | Posted | Count of Participants | Participants | 180 Days |
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Procedure through 180 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 | Single Arm | Single Arm - Use of Indigo Aspiration System with CAT RX Aspiration Catheter (mechanical thrombectomy) in high thrombus burden acute coronary vessel occlusions Indigo Aspiration System: Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4 | 10 | 400 | 144 | 400 | 30 | 400 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | Non-systematic Assessment |
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| Arteriospasm coronary | Cardiac disorders | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | Non-systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
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| Dressler's syndrome | Cardiac disorders | Non-systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Retroperitoneal haematoma | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| Chest pain | General disorders | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
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| Vascular stent occlusion | General disorders | Non-systematic Assessment |
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| Vascular stent thrombosis | General disorders | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
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| Osteomyelitis acute | Infections and infestations | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | Non-systematic Assessment |
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| Sepsis | Infections and infestations | Non-systematic Assessment |
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| Septic shock | Infections and infestations | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Arterial bypass stenosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Procedural pneumothorax | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blood creatinine increased | Investigations | Non-systematic Assessment |
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| Transaminases increased | Investigations | Non-systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | Non-systematic Assessment |
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| Prescynope | Nervous system disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
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| Acute pulmonary eodema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Coronary revascularisation | Surgical and medical procedures | Non-systematic Assessment |
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| Accelerated hypertension | Vascular disorders | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | Non-systematic Assessment |
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| Coronary artery dissection | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
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| Arteriospasm coronary | Cardiac disorders | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Chest pain | General disorders | Non-systematic Assessment |
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| Post procedural cellulitis | Infections and infestations | Non-systematic Assessment |
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| Incision site haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
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| Haematoma | Vascular disorders | Non-systematic Assessment |
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| Haemodynamic instability | Vascular disorders | Non-systematic Assessment |
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| Haemorrhage | Vascular disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Penumbra, Inc. | +1 415-601-9561 | apascua@penumbrainc.com |
| Jan 4, 2023 |
| Prot_SAP_000.pdf |
| 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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