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The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WAVE, as part of the SMART COIL System | Device | WAVE, as part of the SMART COIL System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Adequate Occlusion | Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | Through Study Completion, An Average of 1 Year |
| Safety: Serious Adverse Events (SAEs) | The primary safety endpoints are SAEs within 24 hours post-procedure | Up to 24 Hours Post-Procedure |
| Safety: Device-Related SAE | Device-related SAE up to 7 days or discharge | Through Discharge, up to 7 Days Post-Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Occlusion Rate | Immediate post-procedure occlusion rates: Class 1 - Complete occlusion Class 2 - Residual neck Class 3 - Residual aneurysm The classification of angiographic results was adopted from Roy, Milot, and Raymond. Stroke 2001;32:1998-2004 | Immediate Post-Procedure |
| Efficacy: Retreatment Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
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| Name | Affiliation | Role |
|---|---|---|
| Clemens M Schirmer, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeast Health Medical Center | Dothan | Alabama | 36301 | United States | ||
| Banner UMC Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40908130 | Derived | Schirmer CM, Yoo AJ, Spiotta AM, Kaminsky I, Alshekhlee A, Starke RM, Nicholson A, Zaidat OO, Bohnstedt B, Psychogios MN, Viets R, Asif KS, Stapleton CJ, Mitha AP, Goren O; SURF Study Investigators. Intracranial aneurysm embolization using Penumbra fill and finish coils: 1-year results of a prospective, real-world, multicenter SURF study. J Neurointerv Surg. 2026 Apr 16;18(5):1297-1303. doi: 10.1136/jnis-2025-023633. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System |
| 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 | May 1, 2020 |
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Retreatment rate at final follow-up |
| Through Study Completion, An Average of 1 Year |
| Efficacy: Aneurysm Occlusion Raymond I | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | Immediate Post-Treatment |
| Efficacy: Aneurysm Occlusion Raymond I | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | Through Study Completion, An Average of 1 Year |
| Efficacy: Aneurysm Recanalization or Progressive Thrombosis | Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up | From Immediate Post Procedure Through Study Completion, An Average of 1 Year |
| Safety: Major Ipsilateral Stroke | Occurrence of Major Ipsilateral Stroke | Through Study Completion, An Average of 1 Year |
| Safety: Device-Related SAE | Device related SAE at final follow-up | Through Study Completion, An Average of 1 Year |
| Safety: Morbidity and Mortality | All-cause morbidity and mortality at final follow-up | Through Study Completion, An Average of 1 Year |
| Tucson |
| Arizona |
| 85719 |
| United States |
| Sharp Grossmont | La Mesa | California | 91942 | United States |
| Los Robles | Thousand Oaks | California | 91360 | United States |
| HRI - Swedish | Englewood | Colorado | 80113 | United States |
| St. Anthony's Hospital | Lakewood | Colorado | 80228 | United States |
| Yale New Haven | New Haven | Connecticut | 06320 | United States |
| University of Miami (Jackson Memorial) | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Morton Plant | Tampa | Florida | 33756 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Amita Health | Joliet | Illinois | 60435 | United States |
| Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Metro Health | Wyoming | Michigan | 49519 | United States |
| SSM Health Care | Bridgeton | Missouri | 63044 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Mercy St. Vincent | Toledo | Ohio | 43608 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| UPenn | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| MUSC | Charleston | South Carolina | 29425 | United States |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| University of Tennessee Medical Center, Knoxville | Knoxville | Tennessee | 37996 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| McAllen Medical Center | McAllen | Texas | 78503 | United States |
| Texas Stroke Institute - DFW | Plano | Texas | 75075 | United States |
| Riverside Regional Medical Center | Newport News | Virginia | 23601 | United States |
| Foothills Medical Center | Calgary | T2N 2T9 | Canada |
| University Health Network | Toronto | M5T 2S8 | Canada |
| Bremen-Mitte | Bremen | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| UKSH - Campus Lübeck | Lübeck | 23538 | Germany |
| Maggiore della Carità | Novara | Italy |
| Vall d'Hebron | Barcelona | Spain |
| Donostia | San Sebastián | Spain |
| Universitätsspital Basel | Basel | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
The analysis population consisted of the Intent-to-Treat (ITT) population that included all 572 enrolled patients. The primary analysis, including all effectiveness, safety, and subgroup reporting, were analyzed on this population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | 47 out of 572 participants were not analyzed due to data not collected in the EU. | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report. | Count of Participants | Participants |
| |||||||||||||||||
| Body Mass Index | The analysis population (ITT) contains 558 evaluable participants. | Mean | Standard Deviation | kg/m2 |
|
| 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 | Efficacy: Adequate Occlusion | Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | The analysis population (ITT) contains 396 evaluable participants. | Posted | Count of Participants | Participants | Through Study Completion, An Average of 1 Year |
|
|
| ||||||||||||||||||||||||||
| Primary | Safety: Serious Adverse Events (SAEs) | The primary safety endpoints are SAEs within 24 hours post-procedure | The analysis population (ITT) contains 572 evaluable participants. | Posted | Count of Participants | Participants | Up to 24 Hours Post-Procedure |
|
| |||||||||||||||||||||||||||
| Primary | Safety: Device-Related SAE | Device-related SAE up to 7 days or discharge | The analysis population (ITT) contains 567 evaluable participants. | Posted | Count of Participants | Participants | Through Discharge, up to 7 Days Post-Procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Efficacy: Occlusion Rate | Immediate post-procedure occlusion rates: Class 1 - Complete occlusion Class 2 - Residual neck Class 3 - Residual aneurysm The classification of angiographic results was adopted from Roy, Milot, and Raymond. Stroke 2001;32:1998-2004 | The analysis population (ITT) contains 570 evaluable participants. | Posted | Count of Participants | Participants | Immediate Post-Procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Efficacy: Retreatment Rate | Retreatment rate at final follow-up | The analysis population (ITT) contains 457 evaluable participants. | Posted | Count of Participants | Participants | Through Study Completion, An Average of 1 Year |
|
| |||||||||||||||||||||||||||
| Secondary | Efficacy: Aneurysm Occlusion Raymond I | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | The analysis population (ITT) contains 570 evaluable participants. | Posted | Count of Participants | Participants | Immediate Post-Treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Efficacy: Aneurysm Occlusion Raymond I | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | The analysis population (ITT) contains 396 evaluable participants. | Posted | Count of Participants | Participants | Through Study Completion, An Average of 1 Year |
|
| |||||||||||||||||||||||||||
| Secondary | Efficacy: Aneurysm Recanalization or Progressive Thrombosis | Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up | The analysis population (ITT) contains 395 evaluable participants. | Posted | Count of Participants | Participants | From Immediate Post Procedure Through Study Completion, An Average of 1 Year |
|
| |||||||||||||||||||||||||||
| Secondary | Safety: Major Ipsilateral Stroke | Occurrence of Major Ipsilateral Stroke | The analysis population (ITT) contains 572 evaluable participants. | Posted | Count of Participants | Participants | Through Study Completion, An Average of 1 Year |
|
| |||||||||||||||||||||||||||
| Secondary | Safety: Device-Related SAE | Device related SAE at final follow-up | The analysis population (ITT) contains 572 evaluable participants. | Posted | Count of Participants | Participants | Through Study Completion, An Average of 1 Year |
|
| |||||||||||||||||||||||||||
| Secondary | Safety: Morbidity and Mortality | All-cause morbidity and mortality at final follow-up | The analysis population (ITT) contains 572 evaluable participants. Morbidity through Final Follow-Up was reported in 106 out of 572 participants, and One-Year Mortality was reported in 36 out of 572 participants. | Posted | Count of Participants | Participants | Through Study Completion, An Average of 1 Year |
|
|
Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
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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 - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System | 36 | 572 | 140 | 572 | 20 | 572 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
| ||
| Diabetes insipidus | Endocrine disorders | Non-systematic Assessment |
| ||
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Retroperitoneal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cardiac death | General disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Infusion site haematoma | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Vascular stent occlusion | General disorders | Non-systematic Assessment |
| ||
| Vascular stent thrombosis | General disorders | Non-systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Non-systematic Assessment |
| ||
| Klebsiella sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Meningitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
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| Pneumonia bacterial | 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 |
| ||
| Staphylococcal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Aneurysm perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Burns second degree | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Device placement issue | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Mental status changes postoperative | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Subdural haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Traumatic intracranial 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 |
| ||
| Weaning failure | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Angiogram cerebral abnormal | Investigations | Non-systematic Assessment |
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| Cerebral salt-wasting syndrome | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Aphasia | Nervous system disorders | Non-systematic Assessment |
| ||
| Brain compression | Nervous system disorders | Non-systematic Assessment |
| ||
| Brain oedema | Nervous system disorders | Non-systematic Assessment |
| ||
| Brain stem infarction | Nervous system disorders | Non-systematic Assessment |
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| Cerebellar microhaemorrhage | Nervous system disorders | Non-systematic Assessment |
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| Cerebral artery embolism | Nervous system disorders | Non-systematic Assessment |
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| Cerebral artery occlusion | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral artery thrombosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebral venous sinus thrombosis | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebrospinal fluid leakage | Nervous system disorders | Non-systematic Assessment |
| ||
| Cytotoxic oedema | Nervous system disorders | Non-systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | Non-systematic Assessment |
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| Embolic stroke | Nervous system disorders | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | Non-systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Neurological decompensation | Nervous system disorders | Non-systematic Assessment |
| ||
| Posthaemorrhagic hydrocephalus | Nervous system disorders | Non-systematic Assessment |
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| Ruptured cerebral aneurysm | Nervous system disorders | Non-systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
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| Stroke in evolution | Nervous system disorders | Non-systematic Assessment |
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| Subarachnoid haemorrhage | 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 |
| ||
| VIth nerve paralysis | Nervous system disorders | Non-systematic Assessment |
| ||
| Device dislocation | Product Issues | Non-systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Aneurysm repair | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Cerebral oedema management | Surgical and medical procedures | Non-systematic Assessment |
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| Reduction of increased intracranial pressure | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Ventriculo-peritoneal shunt | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Aneurysm ruptured | Vascular disorders | Non-systematic Assessment |
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| Aortic dissection | Vascular disorders | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
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| Embolism | Vascular disorders | Non-systematic Assessment |
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| Haematoma | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | Non-systematic Assessment |
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| Vascular dissection | Vascular disorders | Non-systematic Assessment |
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| Vasoconstriction | Vascular disorders | Non-systematic Assessment |
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| Vasospasm | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | Non-systematic Assessment |
| ||
| Vascular stent thrombosis | General disorders | Non-systematic Assessment |
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| Aneurysm perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Procedural vomiting | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vascular access site haematoma | 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 pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Cerebral artery embolism | Nervous system disorders | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | Non-systematic Assessment |
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| Cerebral reperfusion injury | Nervous system disorders | Non-systematic Assessment |
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| Embolic cerebral infarction | Nervous system disorders | Non-systematic Assessment |
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| Embolic stroke | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Haematoma | Vascular disorders | Non-systematic Assessment |
| ||
| Peripheral artery occlusion | Vascular disorders | Non-systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Vasospasm | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brooke Lawson | Penumbra, Inc. | +15109952183 | blawson@penumbrainc.com |
| Oct 17, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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