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Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
The registry procedures consist of two phases, retrospective phase and prospective phase.
The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature).
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair |
| |
| bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair |
| |
| fEVAR and bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis | Device | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Vessel Patency | Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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The registry has been designed with broad eligibility criteria to capture real-world data about GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis used as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair.
Patients will be identified from hospital database.
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| Name | Affiliation | Role |
|---|---|---|
| Luca Bertoglio, Prof | spedali civili brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus | 8200 | Denmark | |||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41773696 | Derived | Dioni P, Wanhainen A, Budtz-Lilly J, Dias N, Bonny T, Bertoglio L; EMBRACE study investigator. GORE VIABAHN VBX Balloon-Expandable Endoprostheses as a Bridging Stent With Branched and Fenestrated Endografts in the Endovascular Treatment of Aortic Aneurysms: Protocol for a Retrospective Multicenter Registry (EMBRACE Study). JMIR Res Protoc. 2026 Feb 27;15:e78970. doi: 10.2196/78970. |
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There were 259 patients enrolled and divided as follows: 136 subjects in the BEVAR cohort, 92 in the FEVAR cohort and 31 in the MIXED cohort Fourteen investigators at 14 sites participated in the registry within 6 European countries. All the 14 sites are still active and enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | fEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
| 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 | Oct 5, 2022 | May 20, 2025 |
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| Copenhagen |
| 2100 |
| Denmark |
| IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata | Roma | 00184 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Umberto I | Roma | Italy |
| AMC, Meibergdreef 9 | Amsterdam | 1105 | Netherlands |
| Haukeland Universitetssjukehus | Bergen | 5021 | Norway |
| UNN Tromsø | Tromsø | 9038 | Norway |
| St. Olavs Hospital | Trondheim | Norway |
| Hospital ClÃnico Universitario San Cecilio | Granada | 18016 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Skane University Hospital | Malmö | 214 28 | Sweden |
| Uppsala University Hospital | Uppsala | S-751 85 | Sweden |
| FG001 |
| bEVAR |
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
| FG002 | fEVAR and bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
| COMPLETED | End of 1 year analysis window (POD 455). |
|
| NOT COMPLETED |
|
|
Subjects enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | fEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
| BG001 | bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
| BG002 | fEVAR and bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent |
| BG003 | Total | Total of all reporting groups |
| 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Serum Creatinine | Serum Creatinine, mg/dL | Median | Full Range | mg/dL |
|
| 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 | Number of Participants With Target Vessel Patency | Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up. | Study endpoints were planned and calculated for the two primary cohorts only. Subjects that are not discontinued prior to 1 year window and with imaging within 1 year window. | Posted | Count of Participants | Participants | 12 months |
|
|
|
1 year adverse events for primary cohorts. Time period is up to and including day 365, which is different than study analysis windows.
Serious Adverse Event: Any adverse event that led to any of the following:
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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 | fEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | 5 | 92 | 44 | 92 | 6 | 92 |
| EG001 | bEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | 35 | 136 | 89 | 136 | 7 | 136 |
| EG002 | fbEVAR | Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenetrated or branched stent graft to allow endovascular aneurysm repair GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent | 1 | 31 | 21 | 31 | 3 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Decompensated heart failure | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Ischemic heart disease | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| NSTEMI | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Non-sustained ventricular tachycardia | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Paroxysmal atrial flutter | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Right heart failure | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| STEMI | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Bleeding duodenal ulcer | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Bleeding gastric ulcer | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Blood in stool | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Bowel ischaemia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Bowel ischemia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Hematochezia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Intestinal ischemia | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Paralytic ileus | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Retroperitoneal hematoma | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Superior mesenteric artery dissection | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Fever of unknown origin | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hyposthenia | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| In-stent arterial stenosis | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Multi organ failure | General disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Multiorgan failure | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stent thrombosis | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stent-graft endoleak type IA | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stent-graft endoleak type IB | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stent-graft endoleak type IC | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stent-graft endoleak type II | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Stent-graft endoleak type III | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Unknown cause of death | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular stent-graft occlusion | General disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Acute cholecystitis | Hepatobiliary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Choledocholithiasis | Hepatobiliary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Allergy to antibiotic | Immune system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Anaphylactic reaction to contrast agent | Immune system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Leg infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Nosocomial pneumonia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular graft infection | Infections and infestations | MedDRA Version 28.0 | Systematic Assessment |
| |
| Elbow fracture | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Femoral artery pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Fractured ethmoid | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Intraoperative arterial injury | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Postoperative renal failure | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular access site bleeding | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular graft stenosis | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 28.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA Version 28.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pain of lower extremities | Musculoskeletal and connective tissue disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Advanced lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cerebrospinal fistula | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cerebrospinal fluid rhinorrhoea | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Cognitive impairment | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Ischemic stroke | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Limb paresis | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Neurological impairment | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Paraparesis | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Paraplegia | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Polyneuropathy | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Sensory loss | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Spinal cord ischemia | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Spinal subdural hematoma | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Toxic metabolic encephalopathy | Nervous system disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Device migration | Product Issues | MedDRA Version 28.0 | Systematic Assessment |
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| Device occlusion | Product Issues | MedDRA Version 28.0 | Systematic Assessment |
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| Stent occlusion | Product Issues | MedDRA Version 28.0 | Systematic Assessment |
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| Thrombosis in device | Product Issues | MedDRA Version 28.0 | Systematic Assessment |
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| Confusion | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Confusion state | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Acute nonoliguric renal failure | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Acute on chronic renal failure | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Acute renal insufficiency | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Bladder paralysis | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| End stage renal disease | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Impaired renal function | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Kidney failure | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal artery dissection | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Renal artery occlusion | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Renal artery perforation | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal artery thrombosis | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal function aggravated | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal hematoma | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Renal infarction | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Retention urine | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Acute respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Dyspnea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Acute limb ischemia | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Aneurysm enlargement | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Aortic intramural hematoma | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Aortoiliac occlusive disease | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Arterial bleeding | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Arterial rupture | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Celiac artery occlusion | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| External iliac artery perforation | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Extremity necrosis | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Femoral artery aneurysm | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Femoral artery perforation | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Femoral artery thrombosis | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Hemorrhagic shock | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Hypovolemic shock | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Iliac artery dissection | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Iliac artery stenosis | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Iliac artery thrombosis | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Penetrating aortic ulcer | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Peripheral artery aneurysm rupture | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
| |
| Thoracic aneurysm, ruptured | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Thoracic aortic aneurysm | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Type A aortic dissection | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Type B aortic dissection | Vascular disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stent-graft endoleak type II | General disorders | MedDRA Version 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cinzia Santin, Clinical Study Mgt, Gore Medical Products | WL Gore | +393463645539 | csantin@wlgore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2023 | Jul 29, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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