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The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require interventional treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis | Device | GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events | Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure. | 30 days post treatment |
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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 VBX Stent Graft use, in multiple pathologies and in conditions needing preservation of peripheral vessels.
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| Name | Affiliation | Role |
|---|---|---|
| Mauro Gargiulo, MD | Azienda Ospedaliera Policlinico Sant'Orsola Malpighi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Marie Lannelongue | Paris | France | ||||
| University Hospital Heidelberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389214 | Derived | Usai MV, Gargiulo M, Haulon S, Tielliu I, Bockler D, Verhagen H, Fernandez AM, Austermann MJ. A three-year experience with the balloon expandable GORE VIABAHN VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND trial. J Vasc Surg. 2025 Feb;81(2):319-323.e1. doi: 10.1016/j.jvs.2024.10.002. Epub 2024 Oct 9. | |
| 37572891 |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE VIABAHN VBX Balloon Expandable Endoprosthesis | The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment. |
| 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 | Jun 8, 2020 | Feb 15, 2024 |
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| Heidelberg |
| Germany |
| St. Franziskus Hospital | Münster | Germany |
| Azienda Ospedaliera Policlinico Sant'Orsola Malpighi | Bologna | Italy |
| Fondazione Poliambulanza | Brescia | Italy |
| Azienda Ospedaliero-Universitaria di Padova | Padova | Italy |
| Ospedale di Circolo e Fondazione Macchi | Varese | Italy |
| University Medical Center Groningen | Groningen | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| Hospital Universitario Central de Asturias (HUCA) | Oviedo | Spain |
| University Hospital of Santiago de Compostela | Santiago de Compostela | Spain |
| Usai MV, Gargiulo M, Haulon S, Tielliu I, Boeckler D, Verhagen H, Fernandez AM, Austermann MJ. One-year results of a balloon expandable endoprosthesis as a bridging stent for branched endovascular aortic repair. J Vasc Surg. 2023 Dec;78(6):1376-1382.e2. doi: 10.1016/j.jvs.2023.07.061. Epub 2023 Aug 11. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE VIABAHN VBX Balloon Expandable Endoprosthesis | The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment. |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of Procedural Success and Freedom From VBX Stent Graft-related Serious Adverse Events | Number of study subjects experiencing Procedural Success and free from VBX Stent Graft-related Serious Adverse Events within 30 days of index procedure. Procedural Success is defined as: successful access, delivery, accurate deployment, and withdrawal of catheters with patent VBX Stent Graft at end of procedure. | Posted | Count of Participants | Participants | 30 days post treatment |
|
|
|
1 year
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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 | GORE VIABAHN VBX Balloon Expandable Endoprosthesis | The GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted according to the institution standard of practice in patients needing preservation of peripheral vessels due to multiple pathologies and conditions. GORE VIABAHN VBX Balloon Expandable Endoprosthesis: GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment. | 49 | 280 | 153 | 280 | 15 | 280 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Blood loss anemia | Blood and lymphatic system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Macrocytic anemia | Blood and lymphatic system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute heart failure | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute myocardial infarction type 2 | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Aortic valve insufficiency | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cardiac asthma | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cardiac ischaemia | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cardiac ischemia | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cardiac rupture | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Coronary heart disease | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Decompensation cardiac | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Mitral valve insufficiency | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Non STEMI | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Right heart failure | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Abdominal wall hematoma | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Bowel ischemia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Bowel obstruction | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Celiac artery stenosis | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Femoral hernia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Intestinal polyp bleeding | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Ischemic colitis | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Mesenteric artery embolism | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Mesenteric ischemia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Proctorrhagia | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Retroperitoneal hematoma | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Splenic artery aneurysm | Gastrointestinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Arterial stent occlusion | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Death from natural causes | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Distal stent-induced new entry | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Extravasation of drug | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| In-stent arterial restenosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| In-stent arterial stenosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| In-stent venous restenosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Multi organ failure | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Multiorgan failure | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Reduced general condition | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Renal stent-graft thrombosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent thrombosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft endoleak type IA | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft endoleak type IB | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft endoleak type IC | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft endoleak type II | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft endoleak type III | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft endoleak type IIIA | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft stenosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent-graft thrombosis | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Unknown cause of death | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Wound healing disturbance of | General disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute cholecystitis | Hepatobiliary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hepatic artery stenosis | Hepatobiliary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Bacterial endocarditis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Graft infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Infected toe | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Necrotizing fasciitis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Prosthesis related infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Puncture site infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| SARS-CoV-2 infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Vascular stent infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Arteriovenous fistula site stenosis | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Arteriovenous graft site stenosis | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| False aneurysm | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Femoral artery pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Femur fracture subtrochanteric | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Fractured ribs | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Postimplantation syndrome | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Postoperative hematoma | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Vascular access site occlusion | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Wound bleeding | Injury, poisoning and procedural complications | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Aspiration bronchial | Investigations | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Coxarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Gonarthrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Low back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Ameloblastic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cholangiocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Gallbladder tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Gastric neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Kidney cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Metastatic breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Prostate carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Anterior spinal artery syndrome | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Dural arteriovenous fistula | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hemorrhagic stroke | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Ischemic stroke | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Middle cerebral artery stroke | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Spinal cord ischemia | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Device migration | Product Issues | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent migration | Product Issues | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Stent occlusion | Product Issues | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute on chronic renal failure | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute renal insufficiency | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Renal artery dissection | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Renal function aggravated | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Renal insufficiency | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Acute pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Heel ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hepatectomy | Surgical and medical procedures | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Radical nephrectomy | Surgical and medical procedures | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Aneurysm enlargement | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Aneurysm of aortic arch | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Brachiocephalic vein stenosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Femoral artery thrombosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hematoma | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Hypovolemic shock | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Iliac artery aneurysm | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Iliac artery occlusion | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Iliac artery restenosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Iliac artery stenosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Iliac artery thrombosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Limb ischemia | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Lower limb ischemia | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
| |
| Lymphatic fistula | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Peripheral arterial disease | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Peripheral arterial occlusive disease Fontaine stage III | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Peripheral arterial occlusive disease Fontaine stage IIb | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Phlebitis arm | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Popliteal artery aneurysm | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Subclavian artery thrombosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Superficial femoral arterial stenosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Superficial femoral artery occlusion | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Thoracic aortic aneurysm | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Thoracic aortic aneurysm enlargement | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Type A aortic dissection | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Type B aortic dissection | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Vascular stenosis | Vascular disorders | MedDRA Version 25.1_ | Systematic Assessment |
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| Venous stenosis | Vascular disorders | MedDRA Version 25.1_ | 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 25.1_ | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Austin Phillips | W. L. Gore & Associates | +1 928 864 3641 | agphilli@wlgore.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2020 | Feb 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| >=65 years |
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