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Evaluate real world patient outcomes after treatment of acute, subacute, and chronic proximal lower extremity deep vein thrombosis (DVT) with the ClotTriever Thrombectomy System.
The CLOUT Registry is a prospective, multi-center, observational registry of subjects with proximal lower extremity DVT treated with the ClotTriever Thrombectomy System. The Registry will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through 2 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Analysis Population | Patients with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention. |
| |
| Full Analysis Population | Subjects with proximal lower extremity DVT involving the femoral, common, femoral, iliac veins or inferior vena cava (IVC), alone or in combination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClotTriever | Device | Thrombectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Proportion Participants With Major Adverse Events | The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with proximal lower extremity DVT.
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| Name | Affiliation | Role |
|---|---|---|
| David Dexter, MD | Sentara Vascular Specialists | Principal Investigator |
| Robert Beasley, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's East | Birmingham | Alabama | 35235 | United States | ||
| Affinity Cardiovascular Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35218955 | Background | Dexter DJ, Kado H, Schor J, Annambhotla S, Olivieri B, Mojibian H, Maldonado TS, Gandhi S, Paulisin J, Bunte MC, Angel W, Roberts J, Veerina K, Abramowitz S, Elmasri F, Hnath J, Jung M, Long D, Sanchez L, Cosme O, Skripochnik E, Lodha A, Shaikh A, King C, Bisharat M, Beasley RE; CLOUT Investigators. Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry. J Vasc Surg Venous Lymphat Disord. 2022 Jul;10(4):832-840.e2. doi: 10.1016/j.jvsv.2022.02.013. Epub 2022 Feb 24. | |
| 35714903 |
| Label | URL |
|---|---|
| Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry. | View source |
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The first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks' duration without recent (≤ 3 month) history of venous intervention were enrolled in the Primary Analysis Population. Once the Primary Analysis Population was fully accrued, subjects meeting the study criteria continued to be enrolled and were evaluated as part of the Full Analysis Population.
All patients presenting to the hospital/emergency department with proximal lower extremity deep vein thrombosis (DVT) and meeting all eligibility requirements for enrollment in the CLOUT study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Analysis Population | The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination. |
| 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 | Aug 12, 2020 | Jan 17, 2025 |
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| Index Procedure (approximately 0.5 hours on day 0) |
| Index Procedure (approximately 0.5 hours on day 0) |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| University of California, Los Angeles | Los Angeles | California | 90024 | United States |
| Vascular and Interventional Specialists of Orange County | Orange | California | 92868 | United States |
| University of Colorado, Denver | Denver | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| MedStar Health Research Institution | Washington D.C. | District of Columbia | 20010 | United States |
| Manatee Memorial Hospital | Bradenton | Florida | 34208 | United States |
| Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Lakeland Vascular Institute | Lakeland | Florida | 33801 | United States |
| Mount Sinai Medical Center of Florida | Miami Beach | Florida | 33140 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| Longstreet Clinic | Gainesville | Georgia | 30506 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Surgical Care Associates | Louisville | Kentucky | 40207 | United States |
| Lafayette General | Lafayette | Louisiana | 70503 | United States |
| Opelousas General | Opelousas | Louisiana | 70570 | United States |
| McLaren Bay Heart and Vascular | Bay City | Michigan | 48708 | United States |
| Millenium Cardiology | Farmington Hills | Michigan | 48334 | United States |
| Ascension Genesys Hospital | Grand Blanc | Michigan | 48439 | United States |
| Beaumont Health | Royal Oak | Michigan | 48073 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Saint Luke's Hospital of Kansas City | Lee's Summit | Missouri | 64086 | United States |
| Washington University at St. Louis | St Louis | Missouri | 63130 | United States |
| Hackensack Meridian | Hackensack | New Jersey | 07601 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| SUNY, The University at Buffalo | Buffalo | New York | 14203 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Northwell Health | Staten Island | New York | 10305 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Mercy Health - The Heart Institute | Fairfield | Ohio | 45251 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74133 | United States |
| Thomas Jefferson | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny Health Network Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| Prisma Health - Upstate | Greenville | South Carolina | 29615 | United States |
| Methodist Healthcare Foundation | Germantown | Tennessee | 38138 | United States |
| Houston Healthcare Medical Center | Houston | Texas | 77004 | United States |
| University of Texas Health Sciences Center - Houston | Houston | Texas | 77030 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23452 | United States |
| Providence Sacred Heart | Spokane | Washington | 99204 | United States |
| Gunderson Health | La Crosse | Wisconsin | 54601 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Background |
| Maldonado TS, Dexter DJ, Kado H, Schor J, Annambhotla S, Mojibian H, Beasley RE; CLOUT Registry Investigators. Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. J Vasc Surg Venous Lymphat Disord. 2022 Nov;10(6):1251-1259. doi: 10.1016/j.jvsv.2022.04.015. Epub 2022 Jun 14. |
| 39129803 | Background | Dexter D, Kado H, Shaikh A, Schor J, Annambhotla S, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Bunte MC, Maldonado T, Skripochnik E, Raskin A, Gandhi S, Ichinose E, Beasley R, Mojibian H. Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry. J Soc Cardiovasc Angiogr Interv. 2023 Feb 23;2(2):100585. doi: 10.1016/j.jscai.2023.100585. eCollection 2023 Mar-Apr. |
| 37105663 | Background | Abramowitz SD, Kado H, Schor J, Annambhotla S, Mojibian H, Marino AG, Maldonado TS, Gandhi S, Paulisin J, Bunte MC, Angel W, Roberts J, Veerina K, Long D, Elmasri F, Shaikh A, Beasley RE, Dexter D; CLOUT Investigators. Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry. J Vasc Interv Radiol. 2023 May;34(5):879-887.e4. doi: 10.1016/j.jvir.2022.12.480. |
| 37580422 | Background | Shaikh A, Zybulewski A, Paulisin J, Bisharat M, Mouawad NJ, Raskin A, Ichinose E, Abramowitz S, Lindquist J, Azene E, Shah N, Nguyen J, Cockrell J, Khalsa B, Khetarpaul V, Murrey DA Jr, Veerina K, Skripochnik E, Maldonado TS, Bunte MC, Annambhotla S, Schor J, Kado H, Mojibian H, Dexter D; CLOUT Investigators. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. Cardiovasc Intervent Radiol. 2023 Nov;46(11):1571-1580. doi: 10.1007/s00270-023-03509-8. Epub 2023 Aug 14. |
| 37802419 | Background | Abramowitz S, Marko X, Willis VC, Mills C, Black SA. Association Between 30 Day Villalta Scores and Long Term Post-Thrombotic Syndrome Incidence and Severity Following Acute Deep Vein Thrombosis. Eur J Vasc Endovasc Surg. 2024 Jan;67(1):167-168. doi: 10.1016/j.ejvs.2023.09.045. Epub 2023 Oct 5. No abstract available. |
| 39131784 | Background | Bisharat MB, Ichinose EJ, Veerina KK, Khetarpaul V, Azene EM, Plotnik AN, Hnath J, Trestman E, Harlin SA, Bhat A, Li S, Long GW, O'Connor D, Winokur RS, Zia S, Dexter DJ. One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis. J Soc Cardiovasc Angiogr Interv. 2024 Feb 15;3(3Part A):101307. doi: 10.1016/j.jscai.2024.101307. eCollection 2024 Mar. |
| 37981003 | Background | Abramowitz S, Bunte MC, Maldonado TS, Skripochnik E, Gandhi S, Mouawad NJ, Mojibian H, Schor J, Dexter DJ; CLOUT study collaborators. Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes. Eur J Vasc Endovasc Surg. 2024 Apr;67(4):644-652. doi: 10.1016/j.ejvs.2023.11.017. Epub 2023 Nov 21. |
| 38278173 | Background | Abramowitz S, Shaikh A, Mojibian H, Mouawad NJ, Bunte MC, Skripochnik E, Lindquist J, Elmasri F, Khalsa B, Bhat A, Nguyen J, Shah N, Noor SS, Murrey D, Gandhi S, Raskin A, Schor J, Dexter DJ. Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis. J Vasc Surg Venous Lymphat Disord. 2024 Jul;12(4):101825. doi: 10.1016/j.jvsv.2024.101825. Epub 2024 Jan 24. |
| Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry. | View source |
| Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry. | View source |
| Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. | View source |
| Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. | View source |
| Mechanical Thrombectomy vs. Pharmacomechanical Catheter Directed Thrombolysis for the Treatment of Iliofemoral Deep Vein Thrombosis: A Propensity Score Matched Exploratory Analysis of 12 Month Clinical Outcomes | View source |
| Association Between 30 Day Villalta Scores and Long Term Post-Thrombotic Syndrome Incidence and Severity Following Acute Deep Vein Thrombosis | View source |
| Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis. | View source |
| One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis | View source |
| Primary Analysis Population | The Primary Analysis Population is a subset of the Full Analysis Population, comprising the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 month) history of venous intervention. |
|
| Primary Safety Cohort | The Primary Safety Cohort are the 76 subjects in the Primary Analysis Population who had evaluable data for the primary safety endpoint. |
|
| Primary Effectiveness Cohort | The Primary Effectiveness Cohort are the 89 subjects in the Primary Analysis Population with core laboratory-documented intraluminal thrombus at pre- and post- index procedure who have at least one target venous segment (TVS) treated with the study device. |
|
| Full Analysis Population | The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Analysis Population | The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Height (cm) | Fewer participants were analyzed due to missing baseline height data. | Median | Full Range | cm |
| ||||||||||||||||
| Weight (kg) | Fewer participants were analyzed due to missing baseline weight data. | Median | Full Range | kg |
| ||||||||||||||||
| BMI (kg/m^2) | Baseline BMI data were missing for 7 subjects . | Median | Full Range | 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 Safety Endpoint: Proportion Participants With Major Adverse Events | The primary safety endpoint is the proportion of participants with Major Adverse Events (MAE). MAEs are defined as a composite endpoint triggered when any of four categories of events occurred through 30 days after the index procedure, as observed in the Primary Safety Cohort (the composite endpoints were not observed for the Full Analysis Population:
| The Primary Analysis Population is a subset of the Full Analysis Population, comprising the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 month) history of venous intervention. The Primary Safety Cohort are the 76 subjects in the Primary Analysis Population who had evaluable data for the primary safety endpoint. | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Primary Effectiveness Endpoint (Primary Effectiveness Cohort): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score. | The Primary Analysis Population is a subset of the Full Analysis Population is the first 91 subjects with unilateral acute or subacute DVT of less than or equal to 6 weeks duration without recent (≤ 3 months) history of venous intervention. The Primary Effectiveness Cohort are the 89 subjects in the Primary Analysis Population with core laboratory-documented intraluminal thrombus at pre- and post- index procedure who have at least one target venous segment (TVS) treated with the study device. | Posted | Count of Participants | Participants | Index Procedure (approximately 0.5 hours on day 0) |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Primary Effectiveness Endpoint (Full Analysis Population): Participants With Complete or Near Complete (≥75%) Removal of Venous Thrombus | Complete or near complete (≥75%) removal of venous thrombus from the TVS, as determined by the percent reduction in the Marder score for those segments. When more than one venous segment is treated, the change in Marder score is calculated as the total score for the treated segments prior to intervention with the study device (baseline score) minus the total score after treatment with the study device but before treatment with any adjunctive devices or pharmacologic agents (post-treatment score), divided by the baseline score. | The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination. | Posted | Count of Participants | Participants | Index Procedure (approximately 0.5 hours on day 0) |
|
|
All adverse events were assessed at the index procedure, discharge, 30-day, 6-month, 1-year, and 2-year follow-up visits, study exit (regardless of 2-year follow-up visit completion), and any unscheduled visits prior to the 2-year follow-up visit.
This study captured AEs related to the subject's DVT and its treatment. AEs include all events in the primary safety endpoint, all device/procedure-related AEs, and death. AE counts reflect those at study exit.
Note: 169 patients had unknown mortality status due to withdrawal or loss to follow-up before completing all study visits. The all-cause mortality rate at study exit among patients with confirmed mortality status was 13.6% (45/330).
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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 | Full Analysis Population | The Full Analysis Population consists of 499 subjects with proximal lower extremity DVT involving the femoral, common femoral, iliac veins or inferior vena cava (IVC), alone or in combination. | 45 | 330 | 120 | 499 | 76 | 499 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Blood loss anaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Extrinsic iliac vein compression | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Spontaneous haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vascular stent occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Non-small cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Cervix carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Osteosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Malignant neoplasm of pleura metastatic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Vascular stent stenosis | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pancreatic carcinoma | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Spinal cord injury cervical | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashleigh Willson | Inari Medical | 925-330-3446 | ashleigh.willson@inarimedical.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2021 | Jan 17, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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|
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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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| Other |
|
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| Unknown or Missing |
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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