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To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FlowTriever | Mechanical thrombectomy for pulmonary embolism |
| |
| Conservative Therapy Sub-Study | Anticoagulation medication for pulmonary embolism (as directed by treating physician) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlowTriever System | Device | Thrombectomy |
| |
| Anticoagulation Agents |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Major Adverse Events | MAEs are defined as a composite, when one or more of the following events occur:
The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor. | 48-hours after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device-Related Mortality | Rate of subjects with device related mortality through 48 hours post index procedure | 48-hours after the index procedure |
| Major Bleeding | Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products) |
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Inclusion Criteria:
Clinical signs and symptoms consistent with acute PE
Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*
Exclusion Criteria:
Unable to be anticoagulated with heparin or alternative
Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*
Life expectancy < 30 days, as determined by Investigator
Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
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Patients requiring treatment for pulmonary embolism.
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| Name | Affiliation | Role |
|---|---|---|
| Catalin Toma, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Division of Cardiovascular Disease | Birmingham | Alabama | 35294 | United States | ||
| University of Arizona College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39131977 | Background | Horowitz JM, Jaber WA, Stegman B, Rosenberg M, Fanola C, Bhat AP, Gondi S, Castle J, Ahmed M, Brown MA, Amin R, Bisharat M, Butros P, DuCoffe A, Savin M, Pollak JS, Weinberg MD, Brancheau D, Toma C. Mechanical Thrombectomy for High-Risk Pulmonary Embolism: Insights From the US Cohort of the FLASH Registry. J Soc Cardiovasc Angiogr Interv. 2023 Oct 31;3(1):101124. doi: 10.1016/j.jscai.2023.101124. eCollection 2024 Jan. | |
| 39131661 |
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| ID | Title | Description |
|---|---|---|
| FG000 | FlowTriever | Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 15, 2021 | Sep 8, 2025 |
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| Drug |
Anticoagulation medication |
|
| 48 hours after index procedure |
| Intraprocedural Device-related or Procedure-related Adverse Events | Intraprocedural Device-related or procedure-related adverse events, including:
| Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient. |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Pima Heart and Vascular | Tucson | Arizona | 85741 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Lakeland Vascular Institute | Lakeland | Florida | 33801 | United States |
| Palmetto General Hospital | Miami | Florida | 33016 | United States |
| University of Miami | Miami | Florida | 33125 | United States |
| Mount Sinai Medical Center of Florida | Miami | Florida | 33140 | United States |
| Ascension Sacred Heart | Pensacola | Florida | 32504 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| Rush Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Northwestern University | Evanston | Illinois | 60208 | United States |
| Javon Bea Hospital | Rockford | Illinois | 61103 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Norton Healthcare | Louisville | Kentucky | 40205 | United States |
| Baptist Health Lousville | Louisville | Kentucky | 40207 | United States |
| Opelousas General | Opelousas | Louisiana | 70570 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Ascension Genesys Hospital | Grand Blanc | Michigan | 48439 | United States |
| Ascension Providence Hospital | Madison Heights | Michigan | 48334 | United States |
| Ascension Providence Rochester Hospital | Rochester | Michigan | 48307 | United States |
| Beaumont Health | Royal Oak | Michigan | 48073 | United States |
| St. Joseph Mercy | Ypsilanti | Michigan | 48106 | United States |
| Metropolitan Heart and Vascular Institute | Minneapolis | Minnesota | 55433 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| CentraCare Heart & Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| Missouri Cardiovascular Specialists | Columbia | Missouri | 65201 | United States |
| University of Missouri, Columbia | Columbia | Missouri | 65212 | United States |
| Saint Luke's Hospital of Kansas City | Lee's Summit | Missouri | 64086 | United States |
| Valley Health | Ridgewood | New Jersey | 07450 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| SUNY, The University at Buffalo | Buffalo | New York | 14203 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Jamaica Hospital | Queens | New York | 11418 | United States |
| St. Francis Hospital & Heart Center | Roslyn | New York | 11576 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | United States |
| Methodist Healthcare Foundation | Germantown | Tennessee | 38138 | United States |
| UTMC Knoxville | Knoxville | Tennessee | 37920 | United States |
| St. Thomas West | Nashville | Tennessee | 37205 | United States |
| CardioVoyage | Denison | Texas | 75071 | United States |
| Inova Fairfax | Falls Church | Virginia | 22042 | United States |
| Sentara | Norfolk | Virginia | 23507 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | United States |
| Providence Sacred Heart | Spokane | Washington | 99204 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Allgemeines Krankenhaus AKH Wien | Vienna | Austria |
| UZ Antwerpen | Antwerp | Belgium |
| UZ Brussel | Brussels | Belgium |
| Centre Hospitalier Universitaire de Besançon | Besançon | France |
| Hopital de la Cavale Blanche - CHU Brest | Brest | France |
| CHU Grenoble | Grenoble | France |
| Institut Coeur Poumon - CHU de Lille | Lille | France |
| HCL Hôpital Louis Pradel - Hôpital Cardiologique | Lyon | France |
| European Hospital Georges Pompidou | Paris | France |
| Charité Hospital - Campus Virchow-Klinikum | Berlin | Germany |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Germany |
| University Hospital | Heidelberg | Germany |
| Universitatsklinikum des Saarlandes | Homburg | Germany |
| Helios Kliniken Schwerin | Schwerin | Germany |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands |
| Hospital ClÃnico San Carlos | Madrid | 28040 | Spain |
| Gregorio Maranon University Hospital | Madrid | Spain |
| Inselspital | Bern | Switzerland |
| Kantonsspital Sankt Gallen | Sankt Gallen | Switzerland |
| Unispital | Zurich | Switzerland |
| The Royal Free Hospital | London | United Kingdom |
| The Royal London Hospital, Bart's Health | London | United Kingdom |
| Background |
| Khandhar S, Jaber W, Bunte MC, Cho K, Weinberg MD, Mina B, Stegman B, Pollak J, Khosla A, Elmasri F, Zlotnick D, Brancheau D, Koenig G, Bisharat M, Li J, Toma C. Longer-Term Outcomes Following Mechanical Thrombectomy for Intermediate- and High-Risk Pulmonary Embolism: 6-Month FLASH Registry Results. J Soc Cardiovasc Angiogr Interv. 2023 May 19;2(4):101000. doi: 10.1016/j.jscai.2023.101000. eCollection 2023 Jul-Aug. |
| 37100559 | Background | Bangalore S, Horowitz JM, Beam D, Jaber WA, Khandhar S, Toma C, Weinberg MD, Mina B. Prevalence and Predictors of Cardiogenic Shock in Intermediate-Risk Pulmonary Embolism: Insights From the FLASH Registry. JACC Cardiovasc Interv. 2023 Apr 24;16(8):958-972. doi: 10.1016/j.jcin.2023.02.004. |
| 36349702 | Background | Toma C, Jaber WA, Weinberg MD, Bunte MC, Khandhar S, Stegman B, Gondi S, Chambers J, Amin R, Leung DA, Kado H, Brown MA, Sarosi MG, Bhat AP, Castle J, Savin M, Siskin G, Rosenberg M, Fanola C, Horowitz JM, Pollak JS. Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism. EuroIntervention. 2023 Feb 20;18(14):1201-1212. doi: 10.4244/EIJ-D-22-00732. |
| 35114059 | Background | Toma C, Bunte MC, Cho KH, Jaber WA, Chambers J, Stegman B, Gondi S, Leung DA, Savin M, Khandhar S, Kado H, Koenig G, Weinberg M, Beasley RE, Roberts J, Angel W, Sarosi MG, Qaqi O, Veerina K, Brown MA, Pollak JS. Percutaneous mechanical thrombectomy in a real-world pulmonary embolism population: Interim results of the FLASH registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1345-1355. doi: 10.1002/ccd.30091. Epub 2022 Feb 3. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FlowTriever | Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data was missing for one subject. | Count of Participants | Participants |
| |||||||||||||||||
| Age, Continuous | Data was missing for one subject. | 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 |
| ||||||||||||||||||
| BMI (kg/m^2) | Data was missing for four subjects. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Prior History of PE | Count of Participants | Participants |
| ||||||||||||||||||
| PE Classification | Classifications are defined in 2019 European Society of Cardiology Guidelines for the Diagnosis and Management of Acute Pulmonary Embolism. | Data was missing for two subjects. | Count of Participants | Participants |
| ||||||||||||||||
| Prior History of DVT | Data was missing for one subject. | Count of Participants | Participants |
| |||||||||||||||||
| Concomitant DVT | Data was missing for 10 subjects. | Count of Participants | Participants |
| |||||||||||||||||
| DVT Location | Data was collected for subjects with Concomitant DVT. Data was missing for eight subjects. | Count of Participants | Participants |
| |||||||||||||||||
| History of Cancer | Count of Participants | Participants |
| ||||||||||||||||||
| Active Cancer | Active cancer was collected for subjects with cancer history. | Count of Participants | Participants |
| |||||||||||||||||
| Lytic Contraindication | Data was missing for one subject. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects With Major Adverse Events | MAEs are defined as a composite, when one or more of the following events occur:
The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor. | Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 11 subjects, yielding 988 analyzed subjects. | Posted | Count of Participants | Participants | 48-hours after index procedure |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Device-Related Mortality | Rate of subjects with device related mortality through 48 hours post index procedure | Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 13 subjects, yielding 986 analyzed subjects. | Posted | Count of Participants | Participants | 48-hours after the index procedure |
|
| |||||||||||||||||||||||||||||
| Secondary | Major Bleeding | Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products) | Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 12 subjects, yielding 987 analyzed subjects. | Posted | Count of Participants | Participants | 48 hours after index procedure |
|
| |||||||||||||||||||||||||||||
| Secondary | Intraprocedural Device-related or Procedure-related Adverse Events | Intraprocedural Device-related or procedure-related adverse events, including:
| Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 12 subjects, yielding 987 analyzed subjects. | Posted | Count of Participants | Participants | Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient. |
|
|
Adverse event data was collected from enrollment through 6 months visit or study exit, if exited early.
Reportable AEs include all events considered in the safety analyses (e.g., major bleedings), all device- and/or procedure-related AEs, as well as any event resulting in mortality. Events were adjudicated by independent medical monitor.
Note: 196 patients had unknown mortality status due to early withdrawal or loss to follow-up before completing study visits as planned. The all-cause mortality rate at study exit among patients with confirmed mortality status was 5.6% (45/803).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FlowTriever | Mechanical thrombectomy for pulmonary embolism FlowTriever System: Thrombectomy | 45 | 999 | 125 | 999 | 0 | 999 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemodynamic Instability | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic Stroke | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retroperitoneal Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Shock Haemorrhagic | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial Thombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Stenosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypovolaemic Shock | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intra-Abdominal Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leriche Syndrome | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Post Procedural Pulmonary Embolism | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retroperitoneal Haemorrhage | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vasoplegia Syndrome | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aortic Valve Stenosis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bundle Branch Block, Left | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Failure, Congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest Discomfort | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular Access Site Haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular Access Site Haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Procedure Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Valve Rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Contrast Media Toxicity | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular Access Site Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Colorectal Cancer Stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphoproliferative Disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Mallignant Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastatic Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatic Carcinoma, Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Prostate Cancer, Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Renal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia Pneumococcal | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tracheal Injury | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Heparin-induced Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Plasma Cell Myeloma | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Groin Abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Colon Cancer | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Generalised Tonic-Clonic Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Metabolic Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Mental Status Change | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arterial Repair | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashleigh Willson | Inari Medical, Now Part of Stryker | 925-330-3446 | Ashleigh.Willson@Stryker.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2021 | Sep 8, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| >=65 years |
|
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Intermediate-High Risk |
|
| Intermediate-Low Risk |
|
| Intermediate Risk, Not Further Classified |
|
| No |
|
| No |
|
| Distal Only |
|
| Both |
|
| No |
|
| No |
|
|
|
|