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This study terminated enrollment due to device failures prior to enrollment completion.
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The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac aneurysms.
The Endurant Evo International Clinical Trial is a prospective, multi-center, premarket, non-randomized, single-arm trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Aortic Aneurysm Endovascular repair | Other | Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurant Evo AAA Stent Graft System | Device |
| ||
| Endovascular aneurysm repair (EVAR) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation. | MAEs include the occurrence of any of the following events: All-cause mortality Bowel ischemia Myocardial infarction Paraplegia Procedural blood loss ≥1000 cc Renal failure Respiratory failure Stroke | 30 days |
| Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure. | Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system | Index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality within 30, 183, and 365 days and annually until 5 years. | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point |
Not provided
Inclusion Criteria:
Subject is ≥ 18 years old
Subject understands and voluntarily has signed and dated the Informed Consent approved by the Sponsor and by the Ethics Committee/Institutional Review Board.
Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
Subject is a suitable candidate for elective surgical repair of AAA as evaluated by American Society of Anesthesiologists (ASA) Physical Status Classification System I, II, or III
Subject has an infrarenal abdominal aortic or aortoiliac aneurysm characterized by one or more of the following:
Subject meets all the following anatomical criteria as demonstrated on contrast-enhanced CT or Magnetic Resonance Angiography (MRA) imaging:
Exclusion Criteria:
Subject has a life expectancy ≤ 1 year
Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study
Subject is pregnant
Subject has an aneurysm that is:
Subject requires emergent aneurysm treatment
Subject has a known, untreated thoracic aneurysm >4.5 cm in diameter at time of screening
Subject has been previously treated for an abdominal aortic aneurysm
Subject has a history of bleeding diathesis or coagulopathy
Subject has had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the Endurant Evo AAA stent graft
Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to implantation of the Endurant Evo AAA stent graft
Subject has a conical neck defined as a >4 mm distal increase from the lowest renal artery over a 10 mm length
Subject has a known allergy or intolerance to the device materials
Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment
Subject has significant aortic thrombus and/or calcification at either the proximal or distal attachment centers that would compromise fixation and seal of the device at the discretion of the investigator
Subject has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow
Subject whose arterial access site is not anticipated to accommodate the diameter of the Endurant Evo AAA delivery system (13F-17F) due to vessel size, calcification, or tortuosity
Subject is morbidly obese or has other documented clinical conditions that severely inhibit radiographic visualization of the aorta at the discretion of the investigator
Subject has active infection at the time of the index procedure documented by e.g. pain, fever, drainage, positive culture and/or leukocytosis considered to be clinically significant per investigator discretion
Subject has congenital degenerative collagen disease, e.g., Marfan's Syndrome
Subject has a creatinine level >2.00 mg/dl (or >176.8 µmol/L)
Subject is on dialysis
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| Name | Affiliation | Role |
|---|---|---|
| Hence Verhagen, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Hietzing | Vienna | Austria | ||||
| Wilhelminenspital |
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Patients were screened for enrollment based on the study Inclusion/Exclusion criteria between Jun 2015 and Mar 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endovasculair Repair | Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdominal Aortic Aneurysm Endovasculair Repair | Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Assessed by the Number of Participants Experiencing a Major Adverse Event (MAE) Within 30-days Post-implantation. | MAEs include the occurrence of any of the following events: All-cause mortality Bowel ischemia Myocardial infarction Paraplegia Procedural blood loss ≥1000 cc Renal failure Respiratory failure Stroke | Posted | Count of Participants | Participants | 30 days |
|
|
60-months
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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 | Abdominal Aortic Aneurysm Endovascular Repair | Subjects who were appropriate candidates for endovascular repair of infrarenal abdominal aortic or aortoiliac aneurysms and who met the inclusion and exclusion criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANGINA PECTORIS | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristel Wittebols Sr. Clinical Research Director | Medtronic | 31 (0)43-3566566 | kristel.wittebols@medtronic.com |
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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 | Jul 26, 2019 | Sep 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2015 | Sep 21, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Procedure |
|
Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation. | within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| Number of Subjects With Serious Adverse Events (SAE) | Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation | within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| The Number of Subjects With Aneurysm Rupture | Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
| The Number of Subjects With Major Adverse Events (MAE) | Major adverse events within 183, and 365 days, then annually until 5-Year post-implantation | Within 183, and 365 days, then annually until 5-Year post-implantation |
| the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case. | Through 12-month, 24-month, 36-month, 48-month and 60-month |
| Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm expansion > 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month | 12-month, 24-month, 36-month, 48-month and 60-month |
| Number of Subject With Endoleaks Based on Imaging Findings | Table will show a total number of subjects with endoleak at each follow up time point | 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
| Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
| Number of Subject With Device Deficiencies Based on Imaging Findings | Total number of subject with Any Device Deficiency through the follow up time points. | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
| Vienna |
| Austria |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| UZ Leuven - Campus Gasthuisberg | Leuven | Belgium |
| Odense Universitetshospital | Odense | Denmark |
| Rijnstate - Locatie Arnhem | Arnhem | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Erasmus University Medical Center | Rotterdam | Netherlands |
| Skånes Universitetssjukhus Malmö | Malmö | Sweden |
| Missed Visit |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Primary | Primary Effectiveness Endpoint Assessed by the Number of Subjects With Technical Success at the Index Procedure. | Technical success at the index procedure (as assessed intra-operatively up until closure of the access site), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system | Posted | Count of Participants | Participants | Index procedure |
|
|
|
|
| Secondary | Number of Subjects With All-Cause Mortality (ACM) at Each Follow up | All-cause-mortality within 30, 183, and 365 days and annually until 5 years. | Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subject were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 days, 50 subjects were evaluable. Within 1462-1826 days, 46 subjects were evaluable. | Posted | Count of Participants | Participants | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | Number of Subjects With Aneurysm-related Mortality (ARM) at Each Follow up Time Point | Aneurysm-related mortality within 30, 183, and 365 days, then annually until 5-Year post-implantation | Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 days, 50 subjects were evaluable. Within 1462-1826 days, 46 subjects were evaluable. | Posted | Count of Participants | Participants | within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | Number of Subjects With Secondary Procedures to Correct Type I and III Endoleaks Within Each Follow up Time Point | Secondary procedures to correct Type I and III endoleaks within 183 and 365 day, then annually until 5-Year post-implantation | Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 65 subjects were evaluable. Within 732-1096 days, 57 subjects were evaluable. Note: Reporting of secondary endovascular procedures between 3 and 5 years of follow-up were only required when corresponding to adverse events related to the device, procedure, aneurysm, or subject death. | Posted | Count of Participants | Participants | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | Number of Subjects With Secondary Endovascular Procedures Within Each Follow up Time Point | Secondary endovascular procedures within 30, 183, and 365 days, then annually until 5-Year post-implantation. | Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 67 subjects were evaluable. Within 366-731 days, 65 subjects were evaluable. Within 732-1096 days, 57 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable.* Within 1462-1826 days, 46 subjects were evaluable.* *Reporting of events between 3 -5 years follow-up were only required when related to the device, procedure, aneurysm, or subject death | Posted | Count of Participants | Participants | within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAE) | Serious adverse events within 30, 183, and 365 days, then annually until 5-Year post-implantation | Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable.* Within 1462-1826 days, 46 subjects were evaluable.* *Reporting of events between 3 -5 years follow-up were only required when related to the device, procedure, aneurysm, or subject death | Posted | Count of Participants | Participants | within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | The Number of Subjects With Aneurysm Rupture | Aneurysm rupture within 30, 183, and 365 days, then annually until 5-Year post-implantation | Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 49 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable. | Posted | Count of Participants | Participants | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | The Number of Subjects With Conversion to Ppen Surgery | Conversion to open surgery within 30, 183, and 365 days, then annually until 5-Year post-implantation | Within 0-30 days, 69 subjects were evaluable. Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 66 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable. | Posted | Count of Participants | Participants | Within 30, 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | The Number of Subjects With Major Adverse Events (MAE) | Major adverse events within 183, and 365 days, then annually until 5-Year post-implantation | Within 0-183 days, 69 subjects were evaluable. Within 0-365 days, 69 subjects were evaluable. Within 366-731 days, 66 subjects were evaluable. Within 732-1096 days, 58 subjects were evaluable. Within 1097-1461 Days, 50 subjects were evaluable. Within 1462-1826 days, 45 subjects were evaluable. | Posted | Count of Participants | Participants | Within 183, and 365 days, then annually until 5-Year post-implantation |
|
|
|
| Secondary | the Number of Subjects With Stent Graft Migration (as Compared to 1-month Imaging) | Stent graft migration (as compared to 1-month imaging) through 12-month, 24-month, 36-month, 48-month and 60-month using worst case. | Through 12 Months, 61 subjects were evaluable. Through 24 Months, 56 subjects were evaluable. Through 36 Months, 45 subjects were evaluable. Through 48 Months, 37 subjects were evaluable. Through 60 Months, 31 subjects were evaluable. | Posted | Count of Participants | Participants | Through 12-month, 24-month, 36-month, 48-month and 60-month |
|
|
|
| Secondary | Number of Subjects With Aneurysm Expansion > 5 mm (as Compared to 1-month Imaging) | Aneurysm expansion > 5 mm (as compared to 1-month imaging) at 12-month, 24-month, 36-month, 48-month and 60-month | At 12 Months, 62 subjects were evaluable. At 24 Months, 57 subjects were evaluable. At 36 Months, 43 subjects were evaluable. At 48 Months, 37 subjects were evaluable. At 60 Months, 31 subjects were evaluable. | Posted | Count of Participants | Participants | 12-month, 24-month, 36-month, 48-month and 60-month |
|
|
|
| Secondary | Number of Subject With Endoleaks Based on Imaging Findings | Table will show a total number of subjects with endoleak at each follow up time point | At 1 Month, 66 subjects were evaluable. At 6 Months, 60 subjects were evaluable. At 12 Months, 58 subjects were evaluable. At 24 Months, 54 subjects were evaluable. At 36 Months, 40 subjects were evaluable. At 48 Months, 35 subjects were evaluable. At 60 Months, 30 subjects were evaluable. | Posted | Count of Participants | Participants | 1- month, 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
|
|
|
| Secondary | Number of Subjects With Stent Graft Occlusion Based on Imaging Findings | Stent graft occlusion based on imaging findings through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month | Through 6 Months, 61 subjects were evaluable. Through 12 Months, 60 subjects were evaluable. Through 24 Months, 55 subjects were evaluable. Through 36 Months, 40 subjects were evaluable. Through 48 Months, 34 subjects were evaluable. Through 60 Months, 30 subjects were evaluable. | Posted | Count of Participants | Participants | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
|
|
|
| Secondary | Number of Subject With Device Deficiencies Based on Imaging Findings | Total number of subject with Any Device Deficiency through the follow up time points. | Through 6 Months, 61 subjects were evaluable. Through 12 Months, 65 subjects were evaluable. Through 24 Months, 61 subjects were evaluable. Through 36 Months, 57 subjects were evaluable. Through 48 Months, 55 subjects were evaluable. Through 60 Months, 51 subjects were evaluable. | Posted | Count of Participants | Participants | Through 6-month, 12-month, 24-month, 36-month, 48-month and 60-month |
|
|
|
| 16 |
| 69 |
| 54 |
| 69 |
| 6 |
| 69 |
| ANGINA UNSTABLE | Cardiac disorders | Systematic Assessment |
|
| AORTIC VALVE STENOSIS | Cardiac disorders | Systematic Assessment |
|
| BRADYCARDIA | Cardiac disorders | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | Systematic Assessment |
|
| CARDIAC FAILURE ACUTE | Cardiac disorders | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | Systematic Assessment |
|
| SICK SINUS SYNDROME | Cardiac disorders | Systematic Assessment |
|
| HYDROCELE | Congenital, familial and genetic disorders | Systematic Assessment |
|
| CATARACT | Eye disorders | Systematic Assessment |
|
| DIVERTICULUM | Gastrointestinal disorders | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | Systematic Assessment |
|
| INTESTINAL POLYP | Gastrointestinal disorders | Systematic Assessment |
|
| LOCALISED INTRAABDOMINAL FLUID COLLECTION | Gastrointestinal disorders | Systematic Assessment |
|
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
|
| ASTHENIA | General disorders | Systematic Assessment |
|
| DEATH | General disorders | Systematic Assessment |
|
| DEVICE DAMAGE | General disorders | Systematic Assessment |
|
| DEVICE DISLOCATION | General disorders | Systematic Assessment |
|
| PYREXIA | General disorders | Systematic Assessment |
|
| STENT-GRAFT ENDOLEAK | General disorders | Systematic Assessment |
|
| THROMBOSIS IN DEVICE | General disorders | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | Systematic Assessment |
|
| CHOLECYSTITIS | Hepatobiliary disorders | Systematic Assessment |
|
| BACTERIAL INFECTION | Infections and infestations | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | Systematic Assessment |
|
| GROIN INFECTION | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA LEGIONELLA | Infections and infestations | Systematic Assessment |
|
| POSTOPERATIVE ABSCESS | Infections and infestations | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | Systematic Assessment |
|
| CARBON MONOXIDE POISONING | Injury, poisoning and procedural complications | Systematic Assessment |
|
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| CONCUSSION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | Systematic Assessment |
|
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | Systematic Assessment |
|
| SUBDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| BLOOD POTASSIUM DECREASED | Investigations | Systematic Assessment |
|
| PROPOFOL INFUSION SYNDROME | Metabolism and nutrition disorders | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ACUTE LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| MALIGNANT NEOPLASM OF RENAL PELVIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| METASTATIC SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| NASAL NEOPLASM BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| NON-HODGKIN'S LYMPHOMA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| NON-SMALL CELL LUNG CANCER RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| PROSTATE CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| RECURRENT CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| CAROTID ARTERIOSCLEROSIS | Nervous system disorders | Systematic Assessment |
|
| CEREBRAL INFARCTION | Nervous system disorders | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | Systematic Assessment |
|
| NEUROLOGICAL SYMPTOM | Nervous system disorders | Systematic Assessment |
|
| NEUROTOXICITY | Nervous system disorders | Systematic Assessment |
|
| PARKINSON'S DISEASE | Nervous system disorders | Systematic Assessment |
|
| PETIT MAL EPILEPSY | Nervous system disorders | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PHARYNGEAL HYPERTROPHY | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HIP ARTHROPLASTY | Surgical and medical procedures | Systematic Assessment |
|
| ANEURYSM | Vascular disorders | Systematic Assessment |
|
| AORTIC ANEURYSM RUPTURE | Vascular disorders | Systematic Assessment |
|
| HAEMORRHAGE | Vascular disorders | Systematic Assessment |
|
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | Systematic Assessment |
|
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | Systematic Assessment |
|
| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| VASCULAR STENOSIS | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D001018 |
| Aortic Diseases |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
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| All-cause-mortality (ACM) 0-365 Days |
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| All-cause-mortality (ACM) 366-731 Days |
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| All-cause-mortality (ACM) 732-1096 Days |
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| All-cause-mortality (ACM) 1097-1461 Days |
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| All-cause-mortality (ACM) 1462-1826 |
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| Aneurysm-related mortality (ARM) 0-365 days |
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| Aneurysm-related mortality (ARM) 366-731 days |
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| Aneurysm-related mortality (ARM) 732-1096 days |
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| Aneurysm-related mortality (ARM) 1097-1461 days |
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| Aneurysm-related mortality (ARM) 1462-1826 days |
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| 0-365 Days |
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| 366-731 Days |
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| 732-1096 Days |
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| 1097-1461 Days |
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| 1462-1826 Days |
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| Secondary Endovascular procedure 0-365 days |
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| Secondary Endovascular procedure 366-731 days |
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| Secondary Endovascular procedure 732-1096 days |
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| Secondary Endovascular procedure 1097- 1461 days |
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| Secondary Endovascular procedure 1462-1826 days |
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| Serious Adverse Events (SAE) 0-365 Days |
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| Serious Adverse Events (SAE) 366-731 Days |
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| Serious Adverse Events (SAE) 732- 1096 Days |
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| Serious Adverse Events (SAE) 1097-1461 Days |
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| Serious Adverse Events (SAE) 1462-1826 Days |
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| Aneurysm Rupture 0-365 days |
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| Aneurysm Rupture 366-731 days |
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| Aneurysm Rupture 0732-1096 days |
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| Aneurysm Rupture 1097-1461 days |
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| Aneurysm Rupture 1462-1826 days |
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| Conversion to open surgery 0-365 days |
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| Conversion to open surgery 365-731 days |
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| Conversion to open surgery 732-1096 days |
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| Conversion to open surgery 1097-1461 days |
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| Conversion to open surgery 1462-1826 days |
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| Major Adverse Events (MAEs) 366-731 days |
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| Major Adverse Events (MAEs) 732-1096 days |
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| Major Adverse Events (MAEs) 1097-1461 days |
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| Major Adverse Events (MAEs) 1462-1826 days |
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| Stent Graft Migration through 36 Months |
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| Stent Graft Migration through 48 Months |
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| Stent Graft Migration through 60 Months |
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| Aneurysm Expansion at 36 Months |
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| Aneurysm Expansion at 48 Months |
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| Aneurysm Expansion at 60 Months |
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| Participants with any type of endoleak at 12 Months |
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| Participants with any type of endoleak at 24 Months |
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| Participants with any type of endoleak at 36 Months |
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| Participants with any type of endoleak at 48 Months |
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| Participants with any type of endoleak at 60 Months |
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| Stent Graft Occlusion through 24 months |
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| Stent Graft Occlusion through 36 months |
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| Stent Graft Occlusion through 48 months |
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| Stent Graft Occlusion through 60 months |
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| Any device deficiency through 24 months |
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| Any device deficiency through 36 months |
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| Any device deficiency through 48 months |
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| Any device deficiency through 60 months |
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